Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted expedited approval of a supplemental new drug application (sNDA) for Veklury® (remdesivir) for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or death. This approval expands the role of Veklury, which is the antiviral standard of care for the treatment of patients hospitalized with COVID-19. The expanded indication allows for Veklury to be administered in qualified outpatient settings that can administer daily intravenous (IV) infusions over three consecutive days. The FDA has also expanded the pediatric Emergency Use Authorization (EUA) of Veklury to include non-hospitalized pediatric patients younger than 12 years of age who are at high risk of disease progression.
These actions by the FDA come amidst a surge in COVID-19 cases and the reduced susceptibility to several anti-SARS-CoV-2 monoclonal antibodies (mAbs) due to the Omicron variant. In contrast, Veklury targets the highly conserved viral RNA polymerase, thereby retaining activity against existing SARS-CoV-2 variants of concern. In vitro laboratory testing shows that Veklury retains activity against the Omicron variant. To date, no major genetic changes have been identified in any of the known variants of concern that would significantly alter the viral RNA polymerase targeted by Veklury.
The FDA sNDA approval, pediatric EUA expansion and recently updated National Institutes of Health (NIH) Treatment Guidelines for COVID-19 that additionally recommend Veklury for treatment in non-hospitalized settings, are based on results from the PINETREE Phase 3 randomized, double-blind, placebo-controlled trial. The trial evaluated the efficacy and safety of a three-day course of Veklury for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. An analysis of 562 participants randomly assigned in a 1:1 ratio to receive Veklury or placebo, demonstrated that treatment with Veklury resulted in a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) p=0.008. In the study, no deaths were observed in either arm by Day 28. The safety profile was similar between Veklury and placebo across the variety of outpatient settings in this trial, with the most common treatment emergent adverse events (?5%) in patients taking Veklury being nausea and headache.
"Remdesivir has now helped to treat more than 10 million people around the world with COVID-19 and continues to play a key role in helping to reduce the burden of the pandemic. Based on the most recent data, we now understand that remdesivir is also effective in the early stages of COVID-19 infection, in addition to helping patients who are hospitalized with the disease," said Daniel O'Day, Chairman and Chief Executive Officer, Gilead Sciences. "While we continue to advance remdesivir to benefit more patients in multiple settings, we are also advancing our investigational oral compounds. These are based on the same antiviral mechanism of action as remdesivir and a Phase 1 trial for our oral COVID-19 antiviral, GS-5245 is now underway."
In the United States, Veklury is indicated for the treatment of COVID-19 in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) who are either hospitalized or not hospitalized and are at high risk for progression to severe COVID-19, including hospitalization or death. Veklury is additionally authorized for these uses under the EUA for pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg. Veklury is contraindicated in patients who are allergic to Veklury or any of its components; please see below for additional Important Safety Information for Veklury.
Under the expanded indication for Veklury, non-hospitalized adult and pediatric patients (12 years of age and older and weighing at least 40 kg) with confirmed SARS-CoV-2 infection who are at high risk for COVID-19 disease progression can be treated with a recommended treatment duration of three days to help prevent hospitalization. For hospitalized patients not on mechanical ventilation and/or ECMO, a 5-day course of treatment is recommended, with the option to extend to a total of 10-days as needed. Critically ill patients who require mechanical ventilation and/or ECMO should receive a 10-day course of treatment.
Updates to Veklury Distribution in the U.S.
Gilead has been meeting U.S. and global demand for Veklury for the treatment of hospitalized patients, without disruption since October 2020 after FDA approval. Gilead will now work with distributors to make Veklury available in qualified outpatient facilities, including providing product information to non-hospital settings, to help meet the unprecedented demand for early treatment options brought on by the current COVID-19 surge. In accordance with the recommendations provided by the National Institutes of Health (NIH) COVID-19 Treatment Guidelines, which prioritize treatment for those patients who are at the highest risk of progressing to severe COVID-19, our goal is to continue to ensure uninterrupted supply for inpatient hospital use while expanding to outpatient facilities as well. Gilead will enable outpatient ordering in a tiered approach that will start with hospital outpatient departments due to their experience and familiarity with the administration of Veklury; then outpatient ordering will be available to other qualified outpatient facilities.
Veklury (remdesivir) is a nucleotide analog 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. At this time, more than half of patients hospitalized with COVID-19 in the United States are treated with Veklury. It can help reduce disease progression across a spectrum of disease severity and enable hospitalized patients to recover faster, freeing up limited hospital resources and saving healthcare systems money.
Veklury is approved or authorized for temporary use in approximately 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to more than 10 million patients around the world, including 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 (12 years of age and older and weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, who are:
Veklury should only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion or hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary. Veklury must be administered by intravenous infusion. Veklury is contraindicated in patients who are allergic to Veklury or any of its components. For more information, please see the U.S. full Prescribing Information available at www.gilead.com.
U.S. Important Information for Veklury Emergency Use for Pediatric Patients
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of Veklury for the treatment of COVID-19 in pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg with positive results of direct SARS-CoV-2 viral testing, who are:
Veklury has been authorized by FDA for these emergency uses. Veklury is not FDA-approved for these uses. Veklury is authorized for these uses only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Veklury, unless the authorization is terminated or revoked sooner.
The only authorized dosage form of Veklury for use in pediatric patients under the EUA is Veklury 100 mg for injection, supplied as a lyophilized powder. For information about the authorized use of Veklury, including dosage and administration instructions for pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg, please see the Fact Sheet for Healthcare Providers, available here.
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
Adverse Event Reporting
For use under the EUA, healthcare providers and/or their designee are responsible for mandatory FDA MedWatch reporting of all serious adverse events and medication errors potentially related to Veklury within 7 calendar days from the healthcare provider's awareness of the event. Healthcare providers are additionally encouraged to report adverse events occurring under the approved use of Veklury. MedWatch adverse event reports can be submitted to FDA online at www.fda.gov/medwatch or by calling 1-800-FDA-1088.
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 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, including for the use of Veklury in non-hospitalized patients in the United States; the possibility of unfavorable results from ongoing or additional clinical trials involving Veklury; Gilead's ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, including those involving Veklury, GS-5245 and other investigational oral compounds; Gilead's ability to receive regulatory approvals in a timely manner or at all, including additional regulatory approvals of Veklury, and the risk that any such approvals 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 September 30, 2021, 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 involves 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.
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