Gilead Sciences Inc. (GILD) announced Thursday that the U.S. Food and Drug Administration has approved a supplemental new drug application or sNDA for Veklury (remdesivir) with no dose adjustments to treat COVID-19 in people with mild, moderate and severe hepatic impairment.
The company noted that the approval further supports Veklury’s safety profile as the first and only approved antiviral COVID-19 treatment that can be used across all stages of liver disease.
The approval follows the recent FDA and European Commission decisions to extend the approved use of Veklury to treat COVID-19 in people with severe renal impairment, including those on dialysis.
The latest FDA action was based on results from a Phase 1 study of safety and pharmacokinetics in people with hepatic impairment (GS-US-540-9014). No new safety signals were observed.
Based upon these results, the label has been updated to reflect that no dose adjustment is required across all stages of liver disease. The label still recommends initial hepatic laboratory testing in all patients, before starting Veklury and during treatment as clinically appropriate.
Douglas Dieterich, Director, Institute for Liver Medicine, Professor of Medicine, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, said, “The update to the safety profile and dosing recommendations for Veklury for those living with liver disease is important to this vulnerable population who faces an increased risk of complications from COVID-19. While COVID-19 is no longer a public health emergency, the virus continues to present a threat to those with underlying conditions.”
Veklury is a nucleotide analog prodrug invented and developed by Gilead. Veklury is the antiviral standard of care for the treatment of hospitalized patients with COVID-19 and is a recommended treatment for non-hospitalized patients at high risk of disease progression. So far, Veklury is approved in more than 50 countries worldwide.
Gilead further said it is also working to advance an investigational oral antiviral, obeldesivir, for the treatment of COVID-19.
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