U.S. FDA Advisory Committee Meeting to Discuss COVID-19 Oral Treatment

The U.S. Food and Drug Administration announced an upcoming meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) to discuss Merck and Ridgeback's request for an emergency use authorization (EUA) for molnupiravir, an investigational antiviral drug to treat COVID-19.

On November 30, 2021, the AMDAC will meet to discuss the available data supporting the use of molnupiravir to treat mild-to-moderate COVID-19.

Molnupiravir is an oral antiviral developed initially to treat influenza. Molnupiravir is a bioavailable form of a potent ribonucleoside analog that inhibits replicating multiple RNA viruses, including SARS-CoV-2, the causative agent of COVID-19.

"The FDA is evaluating the safety and effectiveness data submitted by Merck and Ridgeback in their emergency use authorization request for molnupiravir, a new oral treatment for high-risk individuals with a newly diagnosed COVID-19 infection."

"We believe that, in this instance, a public discussion of these data with the agency's advisory committee will help ensure a clear understanding of the scientific data and information that the FDA is evaluating to decide whether to authorize this treatment for emergency use," said Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research, in a press release.

The agency may convene an advisory committee to solicit advice from independent outside experts on various complex scientific, technical, and policy issues at the FDA's discretion.

The FDA does not always convene an advisory committee meeting in connection with EUA reviews but may do so under certain circumstances when discussion with the advisory committee will help inform agency decision making.

The FDA intends to live stream the AMDAC meeting on the agency's webcast from the FDA website.