US FDA seems poised to authorize the oral COVID treatment, but panel discussion will likely highlight the limitations of the antiviral.
The US Food and Drug Administration seems comfortable with authorizing Merck & Co., Inc.’s molnupiravir for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe disease, including hospitalization or death.
But the authorization will be limited to adults, likely carry a pregnancy exclusion, and may be restricted further depending on...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
