Veklury was previously authorized by the FDA for emergency use to treat COVID-19, and is now the first and only approved COVID-19 treatment in the U.S. The drug is indicated for adults and pediatric patients 12 years of age and older for the treatment of COVID-19 and should only be administered in a hospital or healthcare setting.

The approval is based on three randomized controlled trials, including a U.S. National Institute of Allergy and Infectious Diseases (NIAID)-led double blind, placebo-controlled phase III Adaptive COVID-19 Treatment Trial (ACTT)-1 trial that showed treatment resulted in clinically meaningful improvements.

In conjunction with the approval, the FDA also issued a new emergency use authorization (EUA) for the use of Veklury to treat hospitalized pediatric patients under 12 years of age weighing at least 3.5 kg with suspected or laboratory confirmed COVID-19 for whom use of an intravenous (IV) agent is clinically appropriate.