AdComm Narrowly Backs Merck's COVID-19 Pill, Despite Efficacy Questions

The FDA's Antimicrobial Drugs Advisory Committee voted 13 to 10 to recommend emergency authorization of Merck & Co Inc's MRK molnupiravir, antiviral pill to treat COVID-19.

• Molnupiravir, developed with Ridgeback Biotherapeutics, targets part of the virus called the RNA polymerase that has not been changed much by mutations in the Omicron variant. 
• Related: Updated Data Shows Merck's Oral COVID-19 Antiviral Cuts Hospitalization, Death Risk By 30%.
• If the FDA authorizes the drug, it would be the first at-home treatment for the virus nearly two years into the pandemic. 
• The authorization would likely be limited to patients at high risk of developing severe disease.
• The FDA and Merck both recommended against using the drug in kids and pregnant women. Molnupiravir was found to be lethal to embryos in pregnant rats, also causing congenital disabilities and reducing fetal body weight. 
•  The data showed that Molnupiravir also caused other defects that interfered with bone growth in young pups, along with other abnormalities.
• Merck expects to produce 10 million courses of Molnupiravir by the end of 2021, with at least 20 million to be manufactured in 2022.
• Pfizer Inc's PFE rival pill Paxlovid showed an 89% reduction in hospitalizations and deaths in its clinical trial. The FDA could consider that drug within the next few months.
• Also See: EU Backs Merck's COVID-19 Pill For Adults At Risk Of Severe Illness.
• Price Action: MRK shares traded 3.72% higher at $77.70 premarket on the last check Wednesday.