Antiviral Drug Treating COVID-19 Patients Gets U.S. FDA Meeting

The U.S. Food and Drug Administration (FDA) announced on October 14, 2021, 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.

Molnupiravir is an orally bioavailable form of a potent ribonucleoside analog that inhibits replicating multiple RNA viruses, including SARS-CoV-2, the causative agent of COVID-19. Thus, if Authorized, Molnupiravir could be the first oral antiviral for COVID-19 patients.

Molnupiravir was initially developed to treat influenza at Emory University. 

The FDA stated the AMDAC would meet on November 30, 2021, to discuss the available data supporting the use of molnupiravir to treat mild-to-moderate COVID-19 in adults who have tested positive for COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death.

The meeting was scheduled as soon as possible following the submission of the EUA request by the company.

This timeline allows the FDA to thoroughly evaluate the data and information submitted in the EUA request before the meeting and prepare for a robust public discussion with the advisory committee members.

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 helps inform agency decision making." 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," stated Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research, in a press statement.

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 intends to make background materials for the AMDAC meeting available to the public.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical devices.

Note: Florida-based Ridgeback Biotherapeutics L.P. has partnered with Merck to commercialize Molnpiravir. As of October 11, 2021, Merck confirmed it has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021.