An FDA advisory panel will consider whether emergency use authorization for Merck’s (NYSE:MRK) molnupiravir is warranted. The drug would be the first oral antiviral for COVID-19.
Although the conclusions of the Antimicrobial Drugs Advisory Committee are not binding, FDA generally follows its recommendations.
The benefit-risk calculation for molnupiravir has grown more complicated recently.
Over the Thanksgiving holiday, Merck announced that the drug offered a relative risk reduction of 50% against hospitalization or death. An earlier interim analysis of the Phase 2/3 MOVe-OUT clinical trial found it provided a relative risk reduction of 50%.
Developed in collaboration with Ridgeback Biotherapeutics, molnupiravir is an oral prodrug of the antiviral ribonucleoside analog N-hydroxycytidine (NHC). The drug’s mode of action is to contribute to errors in the viral genome during replication.
FDA has signaled it has questions about the drug’s safety profile but that it agreed with Merck’s top-line safety and primary efficacy analyses.
In a briefing document released ahead of the Antimicrobial Drugs Advisory Committee meeting, the agency noted that the drug could be associated with bone and cartilage toxicity, embryo or fetal toxicity and its potential for mutagenicity.
In addition, the FDA cited the potential for enhanced viral evolution as a review issue.
In the days after announcing the revised efficacy figures, MRK shares have fallen 9%, dropping from $82.31 on Nov. 24 to $74.89 on Nov. 29.