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Business Wire 19-Sep-2023 8:30 AM
-- This Positive Opinion Reinforces Veklury's Strong Safety Profile --
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion for the use of Veklury® (remdesivir) to treat people with COVID-19 with mild to severe hepatic impairment. The European Commission (EC) will review the CHMP recommendation and, if adopted, Veklury will become the first and only authorized antiviral COVID-19 treatment that can be used across all stages of liver disease.
Europe has the highest burden of liver disease in the world and cases are expected to grow across many countries. Furthermore, people with liver disease represent a population that is highly vulnerable to COVID-19 and are at increased risk of morbidity and mortality. Safety data in people with severe hepatic impairment are limited and there are few treatment options that are safe and effective.
"Despite lower levels of COVID-19 circulating in the European Union (EU) than at the height of the pandemic, the disease continues to persist and pose a real risk to vulnerable individuals, including those with hepatic impairment," said Anu Osinusi, Vice President, Clinical Research for Hepatitis, Respiratory and Emerging Viruses, Gilead Sciences. "Today's positive CHMP opinion reflects Gilead's ongoing commitment to addressing the unmet needs of those most susceptible to COVID-19."
The clinical benefit of Veklury in hospitalized populations with COVID-19 is supported by randomized controlled trials, real-world evidence and meta-analyses, but the pharmacokinetics of Veklury had not previously been evaluated in patients with hepatic impairment. This positive opinion was based on results from a Phase 1 study of safety and pharmacokinetics in people with hepatic impairment (GS-US-540-9014). Based upon these results, the revised recommendation requires no dose adjustment or liver function testing before or during treatment with Veklury.
"The positive opinion from the Committee helps validate the safety profile of Veklury and is reassuring news to vulnerable populations, such as those living with liver disease that may be facing an increased risk of complications from COVID-19," said Antonella Castagna, MD, Head of Infectious Diseases at San Raffaele Scientific Institute; Professor, Clinic of Infectious Diseases, Vita-Salute San Raffaele University. "Expanding the use of Veklury to those with hepatic impairment will help more people gain access to treatment for COVID-19."
This positive opinion follows recent approvals in the U.S. and the EU which extended the approval of Veklury to treat COVID-19 in people with renal and hepatic impairment.
Gilead conducted a Phase 1, multicenter, open-label, single-dose study to evaluate the pharmacokinetics (PK) of Veklury and its metabolites in participants with normal hepatic function and moderate or severe hepatic impairment. Participants with varying degrees of hepatic impairment and normal hepatic function were enrolled as follows: Cohort 1: 20 participants (10 moderate hepatic impairment and 10 matched normal hepatic function control participants, for a target of 8 evaluable per group), Cohort 2: 12 participants (6 severe hepatic impairment and 6 matched normal hepatic function control participants).
About Gilead's COVID-19 Development Program
Veklury (remdesivir) is a nucleotide analog prodrug invented by Gilead, building on more than a decade of the company's antiviral research. Veklury is the antiviral standard of care 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 plays an important role in reducing disease progression and mortality across a spectrum of disease severity and enabling patients to recover faster.
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 recent Omicron subvariants of concern, including XBB, XBB.1.5 and CH.1.1. Veklury continues to be evaluated against emerging variants of interest and concern, including EG.5, EG.5.1 and BA.2.86.
Veklury is approved in more than 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to more than 13 million patients around the world, including more than 8 million people in middle- and low-income countries through Gilead's voluntary licensing program.
There remains a significant need to develop new and effective oral treatment options for people with COVID-19. Gilead is also working to advance an investigational oral antiviral, obeldesivir, for the treatment of COVID-19. Obeldesivir is a direct-acting nucleoside inhibitor of the of the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), a critical component that the virus uses to replicate.
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) 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.
Warnings and precautions
Dosage and administration
Pregnancy and lactation
About Gilead Sciences
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, COVID-19, 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 and obeldesivir; the possibility that Gilead may make a strategic decision to discontinue development of Veklury and obeldesivir for any indications that are currently under investigation, and as a result, Veklury and obeldesivir may never be commercialized for such indications; uncertainties relating to regulatory applications and related filing and approval timelines, the risk that the EC may not approve Veklury for treatment of COVID-19 patients with mild to severe hepatic impairment; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use; the risk that physicians may not see the benefits of prescribing Veklury; 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 quarter ended June 30, 2023, 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.