FDA Widens Remdesivir’s EUA to Include Mild and Moderate COVID-19 Patients

The FDA announced late Friday that it has decided to expand its Emergency Use Authorization (EUA) for Gilead Sciences’ remdesivir, allowing its use in patients with mild or moderate COVID-19 infections.

The expansion of the EUA means that remdesivir — a drug widely seen as the most promising potential COVID-19 therapy — can now be used to treat all hospitalized adult and pediatric patients regardless of their disease severity.

 “The data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus," said FDA Commissioner Stephen Hahn.

The decision was made following the agency’s evaluation of additional data from two of Gilead’s late-stage trials that evaluated patients with mild to moderate COVID-19 infections.

Gilead Sciences published results from its phase 3 trial of the antiviral on Aug. 21 in the Journal of the American Medical Association, showing that a five-day course of the drug helped patients with moderate COVID-19 pneumonia. The researchers, however, concluded that the findings were of “uncertain clinical importance.” (DID, Aug. 24). The unclear results were apparently enough for the FDA to expand the EUA. Results of the second trial were not publicized.

“The FDA has determined that it is reasonable to believe [remdesivir] may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients,” the agency said. “The agency's review has also concluded that the known and potential benefits of [remdesivir] outweigh the known and potential risks for these uses.” — James Miessler