FDA Expands Authorization Around Remdesivir to Treat COVID-19

January 25, 2022

On January 21, the FDA expanded the use of remdesivir to non-hospitalized adults and children who have mild-to-moderate COVID-19, who are at risk of severe disease. Previously, remdesivir was only available to hospitalized patients. Remdesivir is administered via intravenous infusion over a three day period, and doses will be adjusted for pediatric patients depending on their weight. “Given the similar course of COVID-19 disease, the authorization of [remdesivir] in certain pediatric patients is based on extrapolation of efficacy from adequate and well-controlled studies in adults.”

This decision was based on a clinical trial including 562 participants with mild-to-moderate COVID-19, who had displayed symptoms within the previous 7 days and had at least one risk factor for severe disease. 279 patients were given at least one dose of remdesivir, and 283 were given a placebo. “A total of 4 of 246 patients (1.6%) in the remdesivir group and 21 of 252 (8.3%) in the placebo group had a Covid-19–related medically attended visit by day 28. No patients had died by day 28. Adverse events occurred in 42.3% of the patients in the remdesivir group and in 46.3% of those in the placebo group.” Laboratory tests have shown that remdesivir is effective at neutralizing the Omicron variant.

Gilead, who owns remdesivir, has recently started a Phase 1 clinical trial for a remdesivir pill to combat COVID-19.