The FDA approved an emergency use authorization (EUA) for remdesivir, an investigational antiviral agent, to treat patients hospitalized with severe COVID-19, the agency said Friday.
Authorization was granted on the basis of two clinical trials, including results from a randomized trial of remdesivir released by the National Institute of Allergy and Infectious Diseases in a press release this week. Interim analyses of the trial showed the drug met its primary endpoint, a 31% significantly faster time to recovery over controls.