FDA Expands Emergency Use Authorization for Remdesivir

August 28, 2020 – The U.S. FDA has expanded its Emergency Use Authorization (EUA) for the investigational drug Veklury® (remdesivir), manufactured by Gilead. While not equivalent to FDA approval, the EUA allows for emergency use of the drug under certain conditions.

Initially, the EUA allowed for use of Veklury to treat patients hospitalized with severe COVID-19. Under the expanded EUA, the drug may now be used to treat all hospitalized patients who have suspected or laboratory-confirmed COVID-19, regardless of the severity of disease.

Expansion of the EUA is based on FDA review of the scientific information now available. The FDA has determined it is reasonable to believe Veklury may be effective in treating all patients hospitalized with confirmed or suspected COVID-19. According to the agency, the known and potential benefits of Veklury for this population currently outweigh the known and potential risks.

The full announcement from the FDA can be viewed on the agency’s website.