Below is an excerpt from Medpage Today.
With the release of updated data, oral antiviral molnupiravir to treat high-risk COVID-19 showed only a 30% reduction in the risk of hospitalization and death, according to briefing documents from FDA staff.
The agent's sponsor, Merck, submitted data from the interim analysis of its phase III trial with the request for emergency use authorization (EUA).
This data, first published via press release in early October, showed a 50% risk reduction in all-cause hospitalization and death through day 29 (7.3% vs 14.1% for intervention and placebo groups, respectively).
The FDA's Antimicrobial Drugs Advisory Committee (AMDAC) met Tuesday (Nov 30) to vote on whether the drug's benefits outweigh its risks, and to discuss use of molnupiravir in pregnant women, as well as issues with viral mutations linked with the drug.
Note: The FDA advisory panel voted 13-10 to recommend the oral antiviral molnupiravir for emergency use authorization (EUA) for adults at high risk of progressing to severe COVID-19.
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