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FDA Approves Veklury® (Remdesivir) for the Treatment of Non-Hospitalized Patients at High Risk for COVID-19 Disease Progression
-- Approval Based on Phase 3 Data Showing Veklury Significantly Reduced Risk of Hospitalization By 87% Compared with Placebo -- -- NIH Guidelines Recommend
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"\n-- Approval Based on Phase 3 Data Showing Veklury Significantly Reduced Risk of Hospitalization By 87% Compared with Placebo --\n\n-- NIH Guidelines Recommend Veklury for the Treatment of Non-Hospitalized Patients at High Risk --\n\n-- FDA Expands Pediatric Emergency Use Authorization (EUA) to Include Treatment of Non-Hospitalized Pediatric Patients at High Risk --\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nGilead 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.\n\nThese 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.\n\nThe 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 p...