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 clinical data for his ‘no’ vote. “And I think there are concerns with respect to the uncertainty about the risk for genotoxicity,” he added. “I certainly recognize the need for additional therapeutic agents to be available, particularly with the emergence of developing clades and strains,” Burgess said. “But on the as the question is articulated on the basis of the available data, I voted ‘no.’”
Committee member Dr. Jennifer Le said she appreciated the pharmacologic safety data Merck provided, “yet the pre-marketing studies that we’ve seen here demonstrate highly relevant signals for safety concerns,” said Le, who is a professor of clinical pharmacy at UC San Diego.
Merck’s stock jumped $1.95% to $76.37 in after-hours trading.
Merck developed the drug in collaboration with Ridgeback Biotherapeutics.
If FDA decides to grant emergency use authorization to the drug, it would be the first oral COVID-19 antiviral available in the U.S.
The UK granted conditional approval to the drug in early November.
Filed Under: clinical trials, Drug Discovery, Infectious Disease