FDA AdCom narrowly votes for antiviral molnupiravir for COVID-19 in high-risk adults

The Food and Drug Administration’s Antimicrobial Drugs Advisory Committee (AMDAC) yesterday reviewed the Emergency Use Authorization (EUA) application for molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine developed by US pharma giant Merck & Co (NYSE: MRK), for the treatment of mild to moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19 and/or hospitalization.

The Advisory Committee voted 13-10 that the known and potential benefits of molnupiravir outweigh its known and potential risks for the treatment of mild to moderate COVID-19 in high-risk adult patients who are within five days of symptom onset. The FDA is not bound by the committee’s guidance but takes its advice into consideration.

At Tuesday's AdCom meeting, FDA scientists noted that the drug caused toxicity and birth defects when given at very high doses in animal studies, and said the overall data suggest molnupiravir "may cause foetal harm when administered to pregnant individuals."