FDA's AdComm Meet Tomorrow To Review Safety, Efficacy of Merck's COVID-19 Pill

Key advisers to the FDA are scheduled to meet Tuesday, November 30, to decide emergency use authorization to Merck & Co Inc's MRK experimental pill to treat COVID-19.

• Members of the agency's Antimicrobial Drugs Advisory Committee will scrutinize the Company's data before voting on whether its overall benefits outweigh its risks. 
• Merck asked the FDA in October to clear its drug, molnupiravir, for use in adults with mild-to-moderate COVID-19 who are at risk for severe disease or hospitalization. 
• Updated results showed Merck's drug reduced the risk of hospitalization and death among high-risk Covid patients by 30%.
• Related Link: Merck's COVID-19 Oral Antiviral Cuts Risk of Hospitalization, Death By 50%.
• FDA scientists also noted potential risks of the drug, particularly to pregnant women, as animal studies suggest it could cause harm to the fetus or possible birth defects. 
• No major safety concerns were identified in the trial data. However, the drug may increase the rate of changes in the virus's spike protein, "which, in theory, could enhance SARS-CoV-2 spike protein evolution," the FDA said.
• The agency also pointed out that Merck's safety dataset, which included 593 people, was notably smaller than those provided for other therapies authorized to treat mild-to-moderate COVID-19.
• Price Action: MRK shares are down 6.23% at $74.23 during the market session on the last check Monday.
• Photo by Arek Socha from Pixabay