Panel Mixed Vote on Merck’s Covid Drug

FDA’s Antimicrobial Drugs Advisory Committee 11/30 narrowly voted 13-10 to recommend an emergency use authorization for Merck’s oral antiviral molnupiravir (MOV) for treating Covid-19 patients. An FDA advisory committee briefing document released in advance of the meeting said data show that MOV was associated with a relative risk reduction of 52% in hospitalization or death compared to placebo in adults with mild-to-moderate Covid-19 and at high risk for progression to severe disease.

Some panel members questioned the drug’s efficacy and safety. In the briefing document, FDA also cited concerns with the “known and potential risks of MOV, specifically the nonclinical findings of mutagenicity, embryo-fetal toxicity, and impaired bone and cartilage growth, as well as the potential for MOV to enhance SARS-CoV-2 evolution or immune escape.” FDA and Merck recommended that MOV not be used in those who are pregnant.