Gilead Sciences, Inc. received approval from the U.S. FDA for its antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. As an antiviral drug, Veklury works to stop replication of SARS-CoV-2, the virus that causes COVID-19. The FDA previously authorized Veklury for emergency use to treat COVID-19. Veklury is now the first and only approved COVID-19 treatment in the U.S. The drug is now widely available in hospitals across the country, following early investments to rapidly expand manufacturing capacity to increase supply.

This approval is based on three randomized controlled trials including the recently published, final results of the National Institute of Allergy and Infectious Diseases’ (NIAID) double blind, placebo-controlled Phase 3 ACTT-1 trial, which showed that treatment with Veklury resulted in clinically meaningful improvements across multiple outcome assessments compared with placebo in hospitalized patients with COVID-19.

In the ACTT-1 trial, Veklury significantly improved time to recovery as compared to placebo – by five days in the overall study population (10 vs. 15 days) and seven days in patients who required oxygen support at baseline (11 vs. 18 days). As a secondary endpoint, Veklury also reduced disease progression in patients needing oxygen, resulting in a significantly lower incidence of new mechanical ventilation (13% vs. 23%). In the overall patient population, there was a trend toward reduced mortality with Veklury compared with placebo at Day 29 (11.4% vs. 15.2%).

The FDA also issued a new Emergency Use Authorization (EUA) for the use of Veklury to treat hospitalized pediatric patients under 12 years. This authorization is temporary and may be revoked, and does not take the place of the formal submission, review and approval process for the use of Veklury in this patient population.