FDA’s Antimicrobial Drugs Advisory Committee narrowly concluded that the benefits of Merck’s (NYSE:MRK) COVID-19 pill molnupiravir outweigh the risks.
A total of 13 members of the panel voted in favor of the drug candidate, while 10 voted against it. There were no abstentions.
FDA generally follows the advice of its advisory committees.
“This was clearly a very difficult decision,” said Dr. Michael D. Green, a member of the advisory committee and professor at the University of Pittsburgh School of Medicine. “I would use it in high-risk non-vaccinated individuals,” Green said, adding he would consider the drug for people with obesity and multiple other risk factors. “For pregnancy, I would only use it if there’s no alternative therapy available, and I don’t think I would use it in the first trimester.”
Committee members who voted ‘no’ voiced several concerns.
Dr. Timothy Burgess of the Uniformed Services University cited the unconvincing cli…