The US Food and Drug Administration has approved remdesivir for the treatment of coronavirus infection, the drug's maker, Gilead Sciences.
It is the first drug to be approved for treating Covid-19. The drug, sold under the brand name Veklury, has been used under emergency use authorization since May.
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. Based on the strength of these data, Veklury has become a standard of care for the treatment of COVID-19 in hospitalized patients.