-- If Granted by the European Commission, Veklury Will Become the First and Only Authorized Antiviral Treatment for Pediatric Patients Under 12 Years of Age in the European Union --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion to extend the indication of Veklury ® (remdesivir) for the treatment of pediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19 and pediatric patients (4 weeks of age and older and weighing at least 3 kg) with SARS-CoV-2 with pneumonia who require supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment). The European Commission (EC) will review the CHMP recommendation, and if adopted, Veklury will be the only authorized COVID-19 treatment for adolescents at high risk of progressing to severe COVID-19 and pediatric patients with COVID-19 requiring supplemental oxygen.
"As the pandemic persists, there remains a critical need for proven and effective antiviral therapies like Veklury that can treat some of the most vulnerable in our society," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "We are proud of today's CHMP opinion that represents a positive step toward bridging the treatment gap for children and helping them recover from COVID-19 more quickly."
This positive opinion was based on results from the ongoing CARAVAN Phase 2/3 study, which demonstrated Veklury was generally well-tolerated among pediatric patients hospitalized with COVID-19, with a high proportion of participants showing clinical improvement and recovery, as well as data from trials in adults. Of the 53 pediatric patients enrolled in the CARAVAN study, no new safety signals were apparent for patients treated with Veklury. Overall, 75% and 85% showed clinical improvement (≥2 point increase on an ordinal scale) at Day 10 and last assessment, respectively, while 60% and 83% were discharged by Day 10 and Day 30, respectively. In the study, 38 patients (72%) experienced adverse events (AEs), with 11 patients (21%) experiencing serious adverse events (SAEs) that were determined not to be study-drug related, including three participant deaths, which were consistent with the patients' underlying medical conditions prior to study entry or with COVID-19 during hospitalization.
"As the COVID-19 pandemic evolves, it's important to have effective treatments with well-established safety profiles, including for the vulnerable groups like children to help them recover faster from COVID-19," said Pablo Rojo, MD, PhD, Pediatric Infectious Diseases Specialist of Hospital 12 de Octubre, Madrid, Spain and Associate Professor of Complutense University, Madrid, Spain. "Therefore, the medical community welcomes this CHMP positive opinion for Veklury in pediatric patients and looks forward to the EC decision."
In the European Economic Area (EEA), Veklury is the only antiviral indicated for both the treatment of COVID-19 in adult patients who do not require supplemental oxygen and are at increased risk of developing severe COVID-19, as well as adults and adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment).
Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company's antiviral research. Veklury is a foundation for the treatment of hospitalized patients with COVID-19 and is a recommended treatment for reducing disease progression in non-hospitalized patients at high risk of disease progression. Veklury has an established safety profile and minimal known drug interactions in diverse populations. It can help reduce disease progression across a spectrum of disease severity and enable patients to recover faster, freeing up limited hospital resources and saving healthcare systems money.
Veklury directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. Based on in vitro analyses, Veklury retains antiviral activity against Omicron subvariants BA.2.12.2, BA.4 and BA.5, which are currently the most common circulating variants. Data continue to confirm that Veklury retains antiviral activity against all Omicron subvariants analyzed to date. Gilead continuously evaluates the activity of Veklury against new SARS-CoV-2 variants of concern as they emerge around the world.
Veklury is approved in more than 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to more than 11 million patients around the world, including more than 7 million people in 127 middle- and low-income countries through Gilead's voluntary licensing program. These licenses currently remain royalty-free, reflecting Gilead's existing commitment to enabling broad patient access to remdesivir.
U.S. Indication for Veklury
Veklury ® (remdesivir 100 mg for injection) is indicated for the treatment of COVID-19 in adults and pediatric patients (≥28 days old and weighing ≥3 kg) with positive results of SARS-CoV-2 viral testing, who are:
For more information, please see the U.S. full Prescribing Information available at www.gilead.com .
U.S. Important Safety Information for Veklury
Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Veklury or any of its components.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to effectively manage the supply and distribution of Veklury; Gilead's ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Veklury; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that the EC may not grant marketing authorization for Veklury for treatment of pediatric patients with COVID-19 in a timely manner or at all; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the year ended June 30, 2022, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
U.S. full Prescribing Information for Veklury is available at www.gilead.com .
Veklury, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company's website at www.gilead.com , follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220915006144/en/
Jacquie Ross, Investors (408) 656-8793 Nicole Rodriguez, Media (650) 235-2493
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Enables Contakt World mission to improve health equity and reduce disparities in the fight against Covid-19 and all diseases via award-winning SaaS platform
This document corrects and updates the final paragraph in the body of this news release. No other changes were required in this release.
Contakt World Technologies Corp. (CSE: HELP) (OTC: TLOOF) (FSE: B2I0) (the "Company" or "Contakt World") today announced its agreement in principle with Satcher Health Leadership Institute, Morehouse School of Medicine ("SHLI") to help collect de-identified demographic data for the Health Equity Tracker Project through Smart Health RM and other products and services provided by Contakt World like Engagency. This updates the previously announced collaboration between Contakt World and SHLI now that Health Equity Tracker is operational.
Justin Beck, Chief Visionary Officer ("CVO") for Contakt World, said, "National health equity leader Daniel E. Dawes teaches us that you can't fix problems you don't understand via data. The systemic omission or destruction of racial and ethnic data in public health and healthcare systems mean that disparities often aren't addressed politically - sometimes by design."
He added, "We learned about this on Episode 2 of Contakt World: Truth in Health on iHeartRadio entitled 'COVID The Great Revealer' in my exclusive interview with Daniel E. Dawes, and through Daniel's book published by Johns Hopkins University Press: The Political Determinants of Health. We learned about the oppression of data again, particularly among American Indian and Alaska Natives, speaking with Abigail Echo-Hawk, Chief Research Officer at Seattle Indian Health Board and Director of the Urban Indian Health Institute, on Episode 8 of Contakt World: Truth in Health entitled 'General Disparities? Or Data Genocide?'"
A long-term initiative of the leading institution Satcher Health Leadership Institute at Morehouse School of Medicine ("SHLI"), Health Equity Tracker ("HET") was designed to improve collection and transparency for key demographic data so we can address disparities in healthcare and ultimately improve outcomes for the most vulnerable among us who have suffered from 150+ years systemic inequities. HETP was designed through SHLI's Health Equity Task Force, which involved thought leadership from leaders all over the country in health equity, public health, healthcare, pandemic response, epidemiology, members of Congress in the United States, and Contakt World's co-founder and board member Robin Coleman, a publisher for Johns Hopkins University Press. Funding from Google.org, Gilead Sciences, Annie E. Casey Foundation, and CDC Foundation enabled the project in its formative stages.
"Since the launch of our Health Equity Task Force, Contakt World has been a critical partner in propelling actionable solutions and thought leadership into action," said Daniel E. Dawes. "Now that the HET is operational, Smart Health RM can help collect de-identified data from public health agencies and healthcare where gaps exist as a data partner for Health Equity Tracker. Engagency can also help to identify underserved populations and drive them to their local health department or provider, leveraging Contakt World's agency partnership with Unified Partnerships via iHeartMedia."
"Health agencies, organizations like National Association of County and City Health Officials ("NACCHO"), and public health professionals prioritize health equity in all they do. We hope our data partnership with HET continues to distinguish Contakt World, much like our innovation around communications and community engagement does," added CVO Beck.
Contakt World will soon launch vaccine hesitancy ads targeting unvaccinated populations in hard-to-reach areas for SHLI in a project that included funding from Google.org and Gilead Sciences. Beck finished by saying "I want to emphasize that our long-term view as a ‘phygital' world involves integration of advertising, calls to action, and our SaaS solutions. I believe we can transform the way health agencies and providers connect with their communities, which could improve health outcomes, especially for the hard to reach who suffer from disparities."
Contakt World Contact Zayn Kalyan Interim CEO and Director Direct: 778-938-3367
For more information, please visit the Company's website at www.contakt.world.
Contakt World Investor Contact Lucas A. Zimmerman Senior Vice President - MZ North America Direct: 949-259-4987 contakt@mzgroup.us www.mzgroup.us
Certain information set forth in this press release contains statements that reflect "forward-looking information", as such term is defined under Canadian securities laws ("forward-looking statements"). These forward-looking statements are often identified by words such as "intends", "anticipates", "expects", "believes", "plans", "likely" or similar words. Specifically, this news release includes forward-looking statements regarding: the Company's partnership with SHLI; the HET program's intention and implementation; the planned integration of Smart Health RM and Engagency into the HET program; Contakt's intention to launch vaccine hesitancy ads for SHLI; the Company's long-term view and future business plans. The forward-looking statements reflect the Contakt World's management's expectations, estimates, or projections concerning future results or events, based on the opinions, assumptions and estimates considered reasonable by management at the date the statements are made. Although Contakt World believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements involve risks and uncertainties and undue reliance should not be placed on forward-looking statements, as unknown or unpredictable factors could cause actual results to be materially different from those reflected in the forward-looking statements. The forward-looking statements may also be affected by risks and uncertainties in the business of Contakt World, including those described in the Company's public filings available on www.SEDAR.com. The Company undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change, except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
The Canadian Securities Exchange (CSE) has not reviewed, approved or disapproved the content of this news release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/92368
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Enables Contakt World mission to improve health equity and reduce disparities in the fight against Covid-19 and all diseases via award-winning SaaS platform
Contakt World Technologies Corp. (CSE: HELP) (OTC: TLOOF) (FSE: B2I0) (the "Company" or "Contakt World") today announced its agreement in principle with Satcher Health Leadership Institute, Morehouse School of Medicine ("SHLI") to help collect de-identified demographic data for the Health Equity Tracker Project through Smart Health RM and other products and services provided by Contakt World like Engagency. This updates the previously announced collaboration between Contakt World and SHLI now that Health Equity Tracker is operational.
Justin Beck, Chief Visionary Officer ("CVO") for Contakt World, said, "National health equity leader Daniel E. Dawes teaches us that you can't fix problems you don't understand via data. The systemic omission or destruction of racial and ethnic data in public health and healthcare systems mean that disparities often aren't addressed politically - sometimes by design."
He added, "We learned about this on Episode 2 of Contakt World: Truth in Health on iHeartRadio entitled 'COVID The Great Revealer' in my exclusive interview with Daniel E. Dawes, and through Daniel's book published by Johns Hopkins University Press: The Political Determinants of Health. We learned about the oppression of data again, particularly among American Indian and Alaska Natives, speaking with Abigail Echo-Hawk, Chief Research Officer at Seattle Indian Health Board and Director of the Urban Indian Health Institute, on Episode 8 of Contakt World: Truth in Health entitled 'General Disparities? Or Data Genocide?'"
A long-term initiative of the leading institution Satcher Health Leadership Institute at Morehouse School of Medicine ("SHLI"), Health Equity Tracker ("HET") was designed to improve collection and transparency for key demographic data so we can address disparities in healthcare and ultimately improve outcomes for the most vulnerable among us who have suffered from 150+ years systemic inequities. HETP was designed through SHLI's Health Equity Task Force, which involved thought leadership from leaders all over the country in health equity, public health, healthcare, pandemic response, epidemiology, members of Congress in the United States, and Contakt World's co-founder and board member Robin Coleman, a publisher for Johns Hopkins University Press. Funding from Google.org, Gilead Sciences, Annie E. Casey Foundation, and CDC Foundation enabled the project in its formative stages.
"Since the launch of our Health Equity Task Force, Contakt World has been a critical partner in propelling actionable solutions and thought leadership into action," said Daniel E. Dawes. "Now that the HET is operational, Smart Health RM can help collect de-identified data from public health agencies and healthcare where gaps exist as a data partner for Health Equity Tracker. Engagency can also help to identify underserved populations and drive them to their local health department or provider, leveraging Contakt World's agency partnership with Unified Partnerships via iHeartMedia."
"Health agencies, organizations like National Association of County and City Health Officials ("NACCHO"), and public health professionals prioritize health equity in all they do. We hope our data partnership with HET continues to distinguish Contakt World, much like our innovation around communications and community engagement does," added CVO Beck.
"Since the launch of our Health Equity Task Force, Contakt World has been a critical partner in propelling actionable solutions and thought leadership into action," said Daniel E. Dawes. "Now that the HET is operational, Smart Health RM can help collect de-identified data from public health agencies and healthcare where gaps exist as a data partner for Health Equity Tracker. Engagency can also help to identify underserved populations and drive them to their local health department or provider, leveraging Contakt World's agency partnership with Unified Partnerships via iHeartMedia."
Contakt World Contact Zayn Kalyan Interim CEO and Director Direct: 778-938-3367
For more information, please visit the Company's website at www.contakt.world.
Contakt World Investor Contact Lucas A. Zimmerman Senior Vice President - MZ North America Direct: 949-259-4987 contakt@mzgroup.us www.mzgroup.us
Certain information set forth in this press release contains statements that reflect "forward-looking information", as such term is defined under Canadian securities laws ("forward-looking statements"). These forward-looking statements are often identified by words such as "intends", "anticipates", "expects", "believes", "plans", "likely" or similar words. Specifically, this news release includes forward-looking statements regarding: the Company's partnership with SHLI; the HET program's intention and implementation; the planned integration of Smart Health RM and Engagency into the HET program; Contakt's intention to launch vaccine hesitancy ads for SHLI; the Company's long-term view and future business plans. The forward-looking statements reflect the Contakt World's management's expectations, estimates, or projections concerning future results or events, based on the opinions, assumptions and estimates considered reasonable by management at the date the statements are made. Although Contakt World believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements involve risks and uncertainties and undue reliance should not be placed on forward-looking statements, as unknown or unpredictable factors could cause actual results to be materially different from those reflected in the forward-looking statements. The forward-looking statements may also be affected by risks and uncertainties in the business of Contakt World, including those described in the Company's public filings available on www.SEDAR.com. The Company undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change, except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
The Canadian Securities Exchange (CSE) has not reviewed, approved or disapproved the content of this news release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/92368
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HOOKIPA Pharma (NASDAQ:HOOK) announced that it has made progress in its collaboration with Gilead Sciences (NASDAQ:GILD) for arenavirus-based therapeutics intended to support cures for chronic Hepatitis B virus (HBV) and human immunodeficiency virus (HIV) infections.
As quoted in the press release:
HOOKIPA and Gilead Sciences designed and tested multiple arenaviral vectors expressing HIV and HBV immunogens, optimizing each for potential preclinical immunogenicity, safety and manufacturability. In 2019, HOOKIPA earned multiple Gilead milestone payments for the delivery of research vectors and advancing the programs closer to clinical studies. On the basis of promising preclinical data, Gilead has committed to preparations to advance the HBV and HIV vectors toward development, with the HBV development decision triggering an additional milestone payment to HOOKIPA. To enable the development activities and expanded research programs, Gilead has agreed to reserve manufacturing capacity and expanded the HOOKIPA resources allocated to the Gilead collaboration.
Click here to read the full press release.
Kite, a Gilead Company (Nasdaq: GILD), today announced results from an ongoing Phase 1 study conducted by the National Cancer Institute (NCI) showing that clinical responses were observed with investigational T cell receptor (TCR) cell therapy targeting human papillomavirus type 16 (HPV-16) E7 in solid tumor cancers caused by HPV. These findings were presented today in a poster session at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract #3043).
As quoted in the press release:
Partial responses (Response Evaluation Criteria in Solid Tumors (RECIST); RECIST 1.1) were observed in three out of the seven evaluable patients and another two patients had stable disease. To date, the responses have lasted as long as nine months and have occurred in patients with vulvar, oropharyngeal and anal cancer. Two of these patients had been previously treated with anti-PD1 checkpoint blockade.
“Metastatic HPV-cancers are incurable and poorly addressed by standard therapies,” said Christian S. Hinrichs, MD, Lasker Clinical Research Scholar at the Center for Cancer Research’s Experimental Transplantation and Immunology Branch (ETIB) at the NCI and lead study investigator. “The early results from this Phase 1 trial support the continued evaluation of TCR therapy in HPV-associated cancers.”
Click here to read the full press release.
Gilead Sciences (NASDAQ:GILD) shared the promotion of Dr. Alessandro Riva to executive vice president of Oncology Therapeutics, with responsibility for Gilead’s hematology and oncology programs. As quoted in the press release:
Dr. Riva will become a member of Gilead’s senior leadership team. Dr. Riva joined Gilead in January 2017 as Senior Vice President, Hematology and Oncology Therapeutic Area Head. He has been instrumental in expanding Gilead’s oncology program with the recent acquisition of Kite Pharma, establishing the company as a leader in the field of cellular therapy. He has also guided the strategy and development of Gilead’s broader oncology pipeline during his tenure.
Click here to read the full press release.
- Public-Private Effort to Shift Traditional Model of Hepatitis Management to Primary Care and Help to Expand Care to More People in Need -
Gilead Sciences, Inc. today announced a new public-private initiative with the Partnership for Health Advancement in Vietnam (HAIVN), a collaboration between Brigham and Women's Hospital, Harvard Medical School and Beth Israel Deaconess Medical Center. This multi-year initiative will have a phased approach to help address barriers that limit viral hepatitis diagnosis and care at primary healthcare facilities in Vietnam and the Philippines, two countries with high burdens of hepatitis B and C.
Gilead and HAIVN will work together with a multi-stakeholder coalition, involving national ministries of health, academic stakeholders including the University of Philippines-Manila (UP Manila), provincial hospitals and primary healthcare centers to support this pilot program. The focus of the program will be on person-centered approaches in training non-specialist community-based healthcare providers in prevention and management of viral hepatitis, incorporating education, screening, diagnosis and linkage to care for hepatitis B and C into routine patient visits for at-risk populations. Gilead and HAIVN will also aim to strengthen primary healthcare systems including the referrals and counter-referral systems to enhance coordination between specialist and primary care. The two organizations will make the outcomes and learnings from the initiative public to contribute towards better understanding of adequate public health approaches to improve person-centered, community-based management of viral hepatitis.
"This collaboration will provide evidence to support a shift from the current dependence on scarce and overstretched specialists to a broader group of primary care clinicians while simultaneously strengthening primary health care systems and expanding countries' capacity to diagnose, manage and treat viral hepatitis," said David Duong, MD, MPH, Director of the Harvard Medical School Program in Global Primary Care and Social Change and an internal medicine physician at Brigham and Women's Hospital. "Through this innovative initiative with Gilead, we will apply new patient-centered, community-based models to hepatitis care and treatment, building on the foundation that HAIVN has built."
The initiative will support national priorities for Vietnam and the Philippines: both governments are committed to strengthening primary healthcare and controlling hepatitis. The World Health Organization has set a global target to eliminate viral hepatitis as a public health problem by 2030, calling for 90% of people with hepatitis B and C to be diagnosed, 80% of those eligible for treatment to be treated and a 65% reduction in mortality, in addition to developing preventative actions. 1 However, despite the important gains in biomedical technology and management of viral hepatitis, implementation of best practices and access to diagnostics and treatment in both countries are still significantly limited and inconsistent. At the current pace, Vietnam and the Philippines are not expected to reach WHO targets before 2050.
"This approach has significant potential for application in many other disease areas and low- and middle-income countries where specialist providers are scarce," said Dr. Harald Nusser, Vice President, Head of Global Patient Solutions, Gilead Sciences. "More than proof of concept for eliminating viral hepatitis and strengthening healthcare systems, this initiative demonstrates the potential for the meaningful impact that public, private and academic collaborations can make on improving global health equity and achieving Sustainable Development Goal 3 regarding good health and well-being."
Hepatitis B and C lead to chronic disease in hundreds of millions of people globally and together are the most common cause of liver cirrhosis, liver cancer and viral hepatitis-related deaths. An estimated 354 million people worldwide live with hepatitis B or C, and for most, testing and treatment remain beyond reach. 2 In Vietnam, out of a population of 97 million, nearly 7.8 million people have hepatitis B and over 900,000 have hepatitis C. Based on 2020 estimates from the CDA Foundation's Polaris database, only 30% of Vietnamese people with hepatitis B have been diagnosed and only 3% treated. For hepatitis C, only 14% of cases have been diagnosed and 7% have been treated. 3 In the Philippines, over 10 million people are infected with hepatitis B and nearly 450,000 with hepatitis C, with the care cascade standing at 5% diagnosed and less than 1% treated for hepatitis B and 23% diagnosed and 1% treated for hepatitis C. 3
The 17 Sustainable Development Goals (SDG) were adopted by the United Nations (UN) Member States in 2015, as part of the 2030 Agenda for Sustainable Development. They are call to actions by all countries to unite in a global partnership to ensure peace and prosperity for people and planet. SDG 3 Good Health and Wellbeing is one of the SDGs that Gilead supports to improve global health and sustainable development. SDG 3 consists of several targets, including fighting communicable diseases, achieving universal health coverage, increasing health financing and support for health workforce in developing countries. For more information on the SDGs that Gilead support, please visit www.gilead.com .
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company's website at www.gilead.com , follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
1 WHO Global Health Sector Strategy on Viral Hepatitis 2016-201: Towards Ending Viral Hepatitis https://apps.who.int/iris/bitstream/handle/10665/246177/WHO-HIV-2016.06-eng.pdf
2 https://www.who.int/health-topics/hepatitis#tab=tab_1
View source version on businesswire.com: https://www.businesswire.com/news/home/20220921005778/en/
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--Initiative Creates Groundbreaking New, Royalty Free Inclusive Image Gallery In Strategic Partnership with Shutterstock Studios--
Today, Allergan Aesthetics, an ABBVie company (NYSE: ABBV), and skinbetter science ® announce a new report from their DREAM (Driving Racial Equity in Aesthetic Medicine) Initiative ® along with a long-term partnership with Shutterstock Studios. The report, titled Forces of Beauty ® provides a new understanding of what inclusive and representative beauty looks like today by shedding light on how narrowly defined Eurocentric ideals continue to impact women of color. By surveying over 4,000 women aged 21-65, from multiple geographic locations and backgrounds, the report explores what defines beauty, how beauty impacts women's lives, and the interplay between beauty and race. Some key insights include:
The full report and findings are available for download at DreamforEquity.com
"We are in a position, as industry leaders, to drive the necessary change within the aesthetics industry. We need to create a candid dialogue about racial representation and perceptions within our aesthetics community. We hope that the Forces of Beauty ® Report will contribute to moving us all in the right direction," said Jonah Shacknai , Executive Chairman of skinbetter science ® .
Forces of Beauty ® is the third deliverable from The DREAM Initiative ® , following the successful launches of both the Curriculum for Advancing Racial Equity (CARE) produced by Solomé Rose Consulting, LLC - the American Academy of Dermatology and other leading dermatology societies are supporting the curriculum's inaugural implementation in five highly regarded dermatology residency programs- and the Full Spectrum of Dermatology: A Diverse and Inclusive Atlas , developed by co-editors Misty Eleryan , MD, MS, and Adam Friedman , MD FAAD.
Forces of Beauty ® continues the exploration of the unique relationship between racial/ethnic diversity and beauty for women. The companies are raising awareness about the need for inclusive and representative beauty, providing education, and driving action among medical and consumer audiences.
"Historically, the industry hasn't included all women in its definition of beauty," said Carrie Strom , Senior Vice President at AbbVie and President of Global Allergan Aesthetics. "As industry leaders, our goal is to create a more equitable beauty and aesthetics industry that focuses on diversity, representation, and inclusion. That is what Forces of Beauty ® is about, impacting change and creating a space where the origins of beauty are honored, the definition of beauty is vastly expanded upon, and where uniqueness is the standard."
As part of its multi-media launch, Forces of Beauty ® will be brought to life through an engaging and emotional video series, produced by Shutterstock Studios, Shutterstock's end-to-end custom creative shop. The series, directed by Tiffany Frances , will feature four women as they share their stories and experiences linking directly to dedicated chapters within the report: defining beauty, empowering uniqueness, the history of beauty standards, and appropriation. Each chapter will support the report's overall findings which include: that women of all races strongly believe that "one of us cannot represent all of us"; that the standard of beauty should not be defined by only one group; and, that the origins of beauty and cultural practices be celebrated without being exploited.
Coinciding with the launch of Forces of Beauty ® , the DREAM Initiative ® will also unveil a first-of-its-kind partnership in the aesthetics category with Shutterstock Studios and introduce a royalty free, gallery of diverse images available to the public. The thousands of images will showcase beauty across race, culture, gender, age, ability level, and body type and will bring to life a key takeaway from the Forces of Beauty ® report that "one of us is not the face of all of us." A driving force behind the gallery is the goal to encourage industry peers to leverage these assets within their own efforts, creating a first step towards collective change to a more equitable industry. All inclusive marketing materials will be easily accessible on https://www.shutterstock.com/explore/dream .
"The DREAM Initiative ® brought us this incredible idea to create a more diverse royalty-free image set. And through our partnership on the Forces of Beauty ® report it helped us all recognized an important gap in the market. Most of the visuals used in advertising and branding do not reflect the diversity we see around us every day, and an online search of imagery reveals just how underrepresented many groups are in this space," said Aiden Darné, VP and Global Head of Shutterstock Studios. "Shutterstock interviewed over 2,700 marketers around the world last year and found that 74% of them wished they had access to more diverse content. This realization was the catalyst for a unified pledge to close that gap, and we are excited to partner with the DREAM initiative ® on this journey to put authentic representation at the center of all creative content."
To learn more visit DreamForEquity.com or follow us @AllerganAesthetics and @skinbetter
About Allergan Aesthetics At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.AllerganAesthetics.com or follow us on Instagram and LinkedIn .
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
About skinbetter science ® The skinbetter science ® team of aesthetic experts has a profound understanding of skin aging and what it takes to help defy the effects of time. Tapping into a rich dermatological heritage, the team at skinbetter science ® set out to create a new paradigm in clinical skincare. Cutting-edge, data-driven science is the principal driving force behind all our unique formulations. skinbetter science award-winning products are available exclusively through the leading dermatology, plastic surgery and medical aesthetics practices nationwide. For more information, visit us at Skinbetter.com or follow us on Facebook, Instagram and LinkedIn.
About Shutterstock Studios For 20 years, Shutterstock has contributed to films, documentaries, and storytelling of all types with its vast stock library. Now through its Studios arm, Shutterstock is putting forward stories of its own, leveraging the unique expertise of its production and creative professionals, and archive of over 60 million assets across photo and video, covering royals, film, music, sports, wars, politics and celebrities. Shutterstock Studios specializes in producing branded and commercial content plus documentary and nonfiction films. Studios has rapidly emerged as a best-in-class creative partner for brands globally using physical and virtual production to create evocative content. With the acquisition of TurboSquid, the world's largest 3D marketplace, Shutterstock Studios now offers Web3 services, and 2D and 3D animation.
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The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company") is pleased to announce that it has received a purchase order from the 5-star luxury Four Seasons Hotel San Francisco to become a supplier of gummies for each of the hotel's 277 guest room mini-bars.
"We are thrilled to continue our strategic expansion in the US and honoured to have been selected by the luxury 5-star Four Seasons Hotel San Francisco to be a supplier of Peachy Bees and Watermelon sharks for hotel guest rooms," said Charlie Lamb, President & CEO of GUMY. "We very much look forward to developing a long-term relationship with The Four Seasons Hotel San Francisco, who not only are a world class hotel but who also share our commitment to a more sustainable future for everyone."
The purchase order was received from the Four Seasons Hotel San Francisco on September 12, 2022. The hotel has maintained Five Stars with the world-renowned authority in genuine Five Star service, Forbes Travel Guide. A staple in Bay Area luxury, Four Seasons Hotel San Francisco has been awarded the coveted Forbes Travel Guide Five Stars for the past 19 consecutive years.
"As we've previously mentioned, part of GUMY's multi-channel sales strategy includes targeting hotels and their guest rooms as distribution points for our gummies," said Mr Lamb. "With travel and hotel occupancy now soaring post-COVID, we feel that this will be a very lucrative component of our business model moving forward."
We are a growing community of individuals and organizations who believe small contributions can add up to something big. We sell low sugar, plant based gummy products while raising money (and awareness) to support endangered keystone species. We are the only "better for you" candy company that is built to support our planet's most precious species and ecosystems, while educating our future generations on the steps we must take today, to ensure a viable tomorrow.
Charlie Lamb, President & CEO, Director Telephone: 1(236) 317-2812 - Toll free 1(888) 556-9656 E-mail: investors@shopgummies.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
Certain information set forth in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties. All statements other than statements of historical fact are forward-looking statements, including, without limitation, statements regarding future financial position, business strategy, use of proceeds, corporate vision, proposed acquisitions, partnerships, joint-ventures and strategic alliances and co-operations, budgets, cost and plans and objectives of or involving the Company. Such forward-looking information reflects management's current beliefs and is based on information currently available to management. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "predicts", "intends", "targets", "aims", "anticipates", "may" or "believes" or variations (including negative variations) of such words and phrases or may be identified by statements to the effect that certain actions "may", "could", "should", "would", "might" or "will" be taken, occur or be achieved. A number of known and unknown risks, uncertainties and other factors may cause the actual results or performance to materially differ from any future results or performance expressed or implied by the forward-looking information. These forward-looking statements are subject to numerous risks and uncertainties, certain of which are beyond the control of the Company including, but not limited to, the impact of general economic conditions, industry conditions, risks relating to epidemics or pandemics such as COVID-19, including the impact of COVID-19 on the Company's business, financial condition, and results of operations. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements. The Company does not assume any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by securities laws.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/138005
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Komo Plant Based Foods Inc. (CSE:YUM) (OTCQB:KOMOF) (FRA:9HB) ("Komo") is pleased to announce Quality Foods will be carrying Komo's 2 serving Lasagna, Shepherd's Pie and Mac & Greens as well as both Meal Helpers (Bolognese and Taco Filling) at all Quality Foods locations
Quality Foods is a British Columbia owned, award-winning leader in the Canadian grocery industry with brick and mortar stores in 13 locations in B.C. including Qualicum Foods in Qualicam Beach, Quality Foods in Parksville, Nanoose Bay, Nanaimo (Harewood), Nanaimo (Northridge Village), Port Alberni, Comox, Courtenay, Campbell River, Powell River, Victoria (Langford) and Victoria (View Royal).
"Quality Foods, the Island original, is thrilled to add this new favourite local brand, Komo Comfort Foods, to their 'Good For You' program. Their ready to bake meals aren't only an easy dinner night, they are also hearty and made with only real ingredients. Perfect to add to your veggie night or simply enjoy a meat free option! Best of all, apart from being healthy - Komo tastes delicious," says Quality Food's Reena Kaback
Quality Foods is BC owned and operated since 1982. The Vancouver Island chain is an award-winning leader in the Canadian grocery industry, employing over 1,000 employees primarily on Vancouver Island (and Powell River). Since opening their original store in 1982 as Qualicum Foods in Qualicum Beach on Vancouver Island, they are proudly "an Island Original". Now they are Quality Foods, a BC owned and operated, award-winning leader in the Canadian grocery industry, employing over 1,000 people in thirteen full service grocery stores. The company was acquired by the Jim Pattison Group in 2017.
Komo Plant Based Foods Inc. is a premium plant-based food company that develops, manufactures and sells a variety of plant-based frozen meals that are always hearty, satisfying, and made with wholesome ingredients. At Komo, our mission is to help make plant-based meals a staple on every dinner table by sharing our love for feel-good food that connects the people to the planet. We believe plant-based eating is the future and - Change can start with a single biteTM. Our experienced plant-based innovation and development team recreates vegan versions of traditionally cheesy and meaty classics, with 100% plants. Komo's products are sold direct-to-consumer through our eCommerce website and a distribution network of online and brick and mortar grocery, convenience and natural retailer channels. Our operating subsidiary Komo Comfort Foods launched in 2021 with our flagship products: plant-based Lasagna, Shepherd's Pie and Chickenless Pot Pie and Komo Plant-Based Meal HelpersTM - versatile meal starters to allow the creation of many dishes at home. Komo's newest product is Mac & Greens. All of our products are 100% plant-based, made with wholesome ingredients, free from preservatives and frozen for freshness. Freezing products is a natural and effective way of keeping food products for longer without having to use any preservatives. Komo's meals have a frozen shelf life of 18 months.
Learn more at: www.komocomfortfoods.com and follow on Instagram: @komocomfortfoods
For further information, please contact: William White, President & CEO, Komo Plant Based Foods Inc. will@komoeats.com +1(236) 8000-YUM / (236) 800-0986
The Canadian Securities Exchange has not reviewed, approved or disapproved the contents of this news release.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or Komo's future performance. The use of any of the words "could", "expect", "believe", "will", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Komo's current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, Komo's product development plans, its ability to launch its products on food delivery apps, its ability to retain key personnel, its revenues, and its expectation as to the acceptance of its products by retailer stores and consumers constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. Komo disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.
SOURCE: KOMO Plant Based Foods Inc.
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Gilead Sciences, Inc. (Nasdaq: GILD) today announced the completion of the previously announced transaction to acquire MiroBio, a privately held U.K.-based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, for approximately $405 million in cash. The acquisition provides Gilead with MiroBio's proprietary discovery platform and entire portfolio of immune inhibitory receptor agonists. MiroBio's lead investigational antibody, MB272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator (BTLA) and has entered Phase 1 clinical trials, with the first patient dosed in early August 2022. MB272 targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response.
"Inflammation is a key area of focus for Gilead, and MiroBio's novel discovery platform technology and pipeline provides the opportunity to develop potentially best-in-class large molecule therapeutics to help patients with currently unmet medical needs," said Flavius Martin, Executive Vice President, Research, Gilead Sciences. "This novel approach to inflammatory diseases has the potential to be an important part of providing durable remission for patients living with complex and chronic immune-mediated conditions."
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, inflammation and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including difficulties or unanticipated expenses in connection with integrating the companies, including the effects of the transaction on relationships with employees, other business partners or governmental entities; the risk that Gilead may not realize the expected benefits of this transaction; the ability of Gilead to advance MiroBio's product pipeline and successfully commercialize MiroBio's products; the ability of the parties to initiate and complete clinical trials involving such products in the currently anticipated timelines or at all; the possibility of unfavorable results from one or more of such trials involving such products; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that FDA may not approve any such products in the anticipated indications or on the timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use; any assumptions underlying any of the foregoing; and other risks and uncertainties detailed from time to time in Gilead's periodic reports filed with the U.S. Securities and Exchange Commission (the "SEC"), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company's website at www.gilead.com , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220919005772/en/
Jacquie Ross, Investors Investor_relations@gilead.com
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Five abstracts underscore the long-term safety and efficacy of voclosporin, including in Latino patients and patients with Class V lupus nephritis
Data presentation on pre-clinical asset AUR200 reinforces Aurinia's commitment to autoimmune disease
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the trajectory of autoimmune disease, today announced that data from multiple studies of LUPKYNIS® (voclosporin), used to treat adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE), will be presented at American College of Rheumatology (ACR) Convergence 2022. ACR Convergence 2022 will take place November 10-14 at the Pennsylvania Convention Center in Philadelphia, Pennsylvania.
The abstracts for ACR Convergence 2022 are listed below and available online at: https://acrabstracts.org/meetings/acr-convergence-2022/ .
ACR Convergence 2022 Oral and Poster Presentations:
Title: Long-term Use of Voclosporin in Patients with Class V Lupus Nephritis: Results from the AURORA 2 Continuation Study Presenting author: Amit Saxena, M.D., Assistant Professor, Department of Medicine NYU Grossman School of Medicine Date: Saturday, November 12, 2022 Time: 1:00 p.m - 3:00 p.m ET Session: SLE-Treatment Poster I, Abstract 0355
Title: Early Reductions in Proteinuria with Voclosporin Treatment Across Lupus Nephritis Biopsy Classes: Pooled Data from the AURA-LV and AURORA 1 Trials Presenting author: Anca Askanase, M.D., M.P.H., Professor of Medicine, Columbia University Irving Medical Center, Department of Rheumatology Date: Saturday, November 12, 2022 Time: 1:00 p.m - 3:00 p.m ET Session: SLE-Treatment Poster I, Abstract 0356
Title: Voclosporin Is Effective in Achieving Proteinuria Treatment Targets in Lupus Nephritis Defined by EULAR/ERA Recommendations Presenting author: Hans-Joachim Anders, M.D., Professor of Nephrology and Head of Renal Division, University of Munich (LMU) Date: Saturday, November 12, 2022 Time: 1:00 p.m - 3:00 p.m ET Session: SLE-Treatment Poster I, Abstract 0357
Title: Long-term Safety and Efficacy of Voclosporin in Hispanic and Latino Patients with Lupus Nephritis Presenting author: Ellen M. Ginzler, M.D., M.P.H., Vice Chair for Research, Department of Medicine Chief, Rheumatology Division, SUNY Downstate Health Science University Date: Saturday, November 12, 2022 Time: 1:00 p.m - 3:00 p.m ET Session: SLE-Treatment Poster I, Abstract 0358
Title: AUR200: An Improved BAFF/APRIL Inhibitor with Increased Potency and Safety for the Treatment of B Cell-Mediated Diseases Presenting author: Shawn Morales, Ph.D., Aurinia Pharmaceuticals Date: Monday, November 14, 2022 Time: 9:00 a.m - 10:00 a.m ET Session: Abstracts: B Cell Biology and Targets in Autoimmune and Inflammatory Disease , Abstract 1629
Title: Voclosporin for Lupus Nephritis: Assessment of Long-Term Safety and Efficacy Including Renal Outcome over Three Years of Treatment in the Phase 3 AURORA 1 and AURORA 2 Studies Presenting author: Cristina Arriens, M.D., Clinical Assistant Member, Oklahoma Medical Research Foundation Date: Monday, November 14, 2022 Time: 9:00 a.m - 10:30 a.m ET Session: Abstracts: SLE-Treatment, Abstract 1653
About Lupus Nephritis LN is a serious manifestation of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and about one-third of these people are diagnosed with lupus nephritis at the time of their SLE diagnosis. About 50 percent of all people with SLE may develop lupus nephritis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.
About LUPKYNIS LUPKYNIS® is the first U.S. FDA- and EC-approved oral medicine for the treatment of adult patients with active lupus nephritis (LN). LUPKYNIS is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The recommended starting dose of LUPKYNIS is three capsules twice daily with no requirement for serum drug monitoring. Dose modifications can be made based on Aurinia's proprietary personalized eGFR-based dosing protocol. Boxed Warning, warnings, and precautions for LUPKYNIS are consistent with those of other CNI-immunosuppressive treatments.
About Aurinia Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis. The Company's head office is in Victoria, British Columbia, its U.S. commercial office is in Rockville, Maryland. The Company focuses its development efforts globally.
INDICATION AND IMPORTANT SAFETY INFORMATION
LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.
BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS
Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.
LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.
Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.
Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections (including opportunistic infections), which may lead to serious, including fatal, outcomes.
Nephrotoxicity: LUPKYNIS, like other CNIs, may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity.
Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy.
Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions.
Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia.
QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.
Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.
Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.
Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with narrow therapeutic windows when co-administered.
The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.
Pregnancy/Lactation: May cause fetal harm. Advise not to breastfeed.
Renal Impairment: Not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. Severe renal impairment: Reduce LUPKYNIS dose.
Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose. Severe hepatic impairment: Avoid LUPKYNIS use.
Please see Prescribing Information , including Boxed Warning, and Medication Guide for LUPKYNIS.
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Investors DeDe Sheel dsheel@auriniapharma.com
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