FDA Approves Gilead’s Remdesivir for Covid-19

FDA has approved a Gilead Sciences NDA for Veklury (remdesivir), indicated for treating patients with Covid-19 that requires hospitalization. Remdesivir is the first treatment approved for treating Covid-19, according to the agency, and it previously was available in the U.S. under an emergency use authorization for treating hospitalized patients with severe Covid-19. The approval covers the use in adult and pediatric patients 12 years of age and older and weighing at least 88 pounds. Pediatric trials are ongoing, the agency says.

Approval was based on data from two Phase 3 clinical studies that demonstrated treatment with Veklury led to faster time to recovery compared with placebo and that a five-day or 10-day treatment duration led to similar clinical improvement. Veklury has been approved by the European Union, Japan and other regulatory agencies.