FDA Panel Narrowly Recommends First Oral COVID-19 Antiviral Treatment

On Tuesday, the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) narrowly recommended that the agency issue its first emergency use authorization (EUA) for Merck’s investigational oral antiviral medication for the treatment of mild to moderate COVID-19 in adults with high risk of severe COVID-19 or hospitalization.

The drug, molnupiravir, has been shown to have a relative risk reduction of hospitalization or death of 30 percent compared to a placebo group. The Merck drug is intended to be taken within five days of symptom onset, twice per day for five days.

Members of the FDA AMDAC raised some concerns around the effectiveness of the pills, potential impacts on pregnant persons, and the potential for the development of harmful mutations in the spike protein of the virus. Despite these concerns, the panel voted 13-10 to recommend the FDA issue an EUA for the product. A decision from the FDA is anticipated over the coming days.

Another antiviral pill from Pfizer is anticipated to be reviewed by the FDA AMDAC over the coming weeks. The Pfizer drug has been found to have significantly better effectiveness against hospitalization and death based on clinical trial data completed to date.

Additional information on the Merck drug and FDA panel vote is available here.