Divided US FDA AdComm Backs Molnupiravir Authorization But Wants More Studies

Dec 01 2021

• By Brenda Sandburg

Listen to this article

In 13-10 vote, panel finds reduction in COVID-19 hospitalizations and deaths outweighs risks. Four members say FDA should reconsider authorization if a more effective and safer therapy comes along. They concur molnupiravir should not be recommended for use in pregnancy but available to those who want it.

Molnupiravir — US FDA advisory committee favors FDA authorization of Merck's molnupiravir • Source: Alamy

A slim majority of US Food and Drug Administration advisory committee members concluded that Merck & Co., Inc.’s molnupiravir showed sufficient efficacy in reducing hospitalizations and deaths in those with mild to moderate COVID-19 to outweigh potential risks. But many expressed reluctance in making this call and recommended that the company conduct additional studies, including in the vaccinated and immunocompromised.

At its 30 November meeting, the Antimicrobial Drugs Advisory Committee voted 13-10 that the known and potential benefits of molnupiravir...

More from US FDA Performance Tracker

Ocaliva Confirmatory Trial Failed To Verify Benefit In Primary Biliary Cholangitis, US FDA Says
Sep 11 2024
• By Sue Sutter
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 FDA Advisory Committee Meetings
Aug 23 2024
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
EU Filings Tracker TEST
Aug 22 2024
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.
US FDA Adcomm Reform Ideas: Neutral Facilitator As Chair, Public Hearing Lottery Process Tweaks
Aug 21 2024
• By Sue Sutter
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.

More from Regulatory Trackers

Ocaliva Confirmatory Trial Failed To Verify Benefit In Primary Biliary Cholangitis, US FDA Says
Sep 11 2024
• By Sue Sutter
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.
Global Pharma Guidance Tracker – August 2024
Sep 09 2024
• By Vibha Sharma
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Recent And Upcoming FDA Advisory Committee Meetings
Aug 23 2024
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.