FDA Approves Veklury (remdesivir) for COVID-19 Treatment in Patients With Severe Renal Impairment, Including Those on Dialysis

FOSTER CITY, Calif.–(BUSINESS WIRE) July 14, 2023 — Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury^® (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis. With this approval, Veklury is now the first and only approved antiviral COVID-19 treatment that can be used across all stages of renal disease. More than 1 in 7 (37 million) people in the U.S. are estimated to have chronic kidney disease (CKD) and are at increased risk of COVID-19 related morbidity and mortality. The U.S. approval comes on the heels of the European Commission decision to extend the approved use of Veklury to treat COVID-19 in people with severe renal impairment, including those on dialysis, which was adopted on June 26, 2023.

“Patients with advanced CKD and end-stage kidney disease (ESKD) are at high risk for severe COVID-19 with hospitalization and mortality rates remaining high, even for those who are vaccinated. With limited clinical trial information for COVID-19 patients with advanced CKD and ESKD, few antiviral treatment options currently exist for this population,” said Meghan Sise, MD, Department of Nephrology at Massachusetts General Hospital. “This latest update to the prescribing information for remdesivir now includes patients with advanced CKD and ESKD and this is an important advance for a population that remains highly vulnerable to the impacts of COVID-19.”

The updated prescribing information for Veklury does not require dose adjustments for renally-impaired patients and removes the requirement for eGFR testing before or during treatment with Veklury. The clinical benefit of Veklury in hospitalized patients with COVID-19 is supported by randomized controlled trials, real-world evidence and meta-analyses, but its use has previously been limited among patients with severe renal impairment due to insufficient data. This approval for use in patients with severe renal impairment was based on results from a Phase 1 study (GS-US-540-9015), as well as results from the Phase 3 REDPINE trial that demonstrated the pharmacokinetics (PK) and safety profile of Veklury in this population. No new safety signals were observed in either of the studies.

“The approval by the FDA of Veklury for the treatment of patients with renal impairment reflects the urgency to make this medicine available to these patients, and underscores the established safety profile for Veklury,” said Anu Osinusi, Vice President, Clinical Research for Hepatitis, Respiratory and Emerging Viruses at Gilead Sciences. “Gilead is committed to discovering, developing and providing transformational therapies for COVID-19, including for the most vulnerable populations at risk of developing severe disease.”

In the United States, Veklury is indicated for the treatment of COVID-19 in adults and pediatric patients (28 days and older and weighing at least 3 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 contraindicated in patients who are allergic to Veklury or any of its components; please see below for additional Important Safety Information for Veklury.

About GS-US-540-5912 (REDPINE)

Gilead conducted a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study (REDPINE) evaluating the efficacy and safety of Veklury in patients with severely reduced kidney function who are hospitalized with COVID-19. The trial enrolled 243 hospitalized adult participants with confirmed COVID-19 and renal impairment who were randomized in a 2:1 manner to receive Veklury (n=163) or placebo (n=80), in addition to standard of care, and were stratified by ESKD, high-flow oxygen requirement, and region (US vs. ex-US). The study closed prematurely due to feasibility issues and was underpowered to assess for efficacy because of lower-than-expected enrollment. No new safety signals were observed in the study and no additional adverse reactions to Veklury were identified in 163 hospitalized patients with confirmed COVID-19 and acute kidney injury (AKI) (n=60), CKD (eGFR <30 mL/minute) (n=44) or ESKD (eGFR <15 mL/minute) requiring hemodialysis (n=59) receiving Veklury for up to 5 days.

Pharmacokinetic data was obtained from the REDPINE study, as well as a Phase 1 open-label, parallel-group, single-dose study (GS-US-540-9015). Given the observed PK and the absence of any new safety signals associated with increased metabolite levels in patients with severely reduced kidney function, no dose adjustment of Veklury is recommended in patients with any degree of renal impairment, including those on dialysis.

About Gilead’s COVID-19 Development Program

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 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 BQ.1.1 and XBB. 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 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. Once metabolized, obeldesivir works in the same way as Veklury to halt SARS-CoV-2 virus replication.

U.S. Indication for Veklury

VEKLURY 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

Contraindication

Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Veklury or any of its components.

Warnings and precautions

Adverse reactions

Drug interactions

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 and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

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; uncertainties relating to regulatory applications and related filing and approval timelines; 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 March 31, 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.

Source: Gilead Sciences, Inc.

Posted: July 2023

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FDA Approves Veklury (remdesivir) for the Treatment of Non-Hospitalized Patients at High Risk for COVID-19 Disease Progression – January 21, 2022
FDA Approves Veklury (remdesivir) for the Treatment of COVID-19 – October 22, 2020
Gilead Submits New Drug Application to U.S. Food and Drug Administration for Veklury (remdesivir) for the Treatment of COVID-19 – August 10, 2020

Veklury (remdesivir) FDA Approval History

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