PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
News|Articles|December 6, 2021
FDA Panel Recommends Merck’s COVID-19 Pill
Author(s)Pharmaceutical Technology Editors
Following mixed results from clinical trials, a panel of outside experts voted 13-10 to recommend Merck’s pill for Emergency Use Authorization.
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The Antimicrobial Drugs Advisory Committee (AMDAC) voted on Nov. 30, 2021, to recommend an Emergency Use Authorization (EUA) for molnupiravir, an experimental antiviral oral COVID-19 medication from Merck—known as MSD outside of the United States and Canada—and Ridgeback Biotherapeutics. While questions about its risks cropped up following initial positive findings, a 13-10 decision was ultimately made in favor of its recommendation.
Merck announced positive preliminary results for molnupiravir on Oct. 1st, 2021.
However, following an evaluation of the full population, this risk reduction was instead found to be approximately 30%. This reduced effectivity, in tandem with concerns about potential risks to fetuses and DNA, led to many members of the panel to believe the potential risk was not worth the demonstrated benefit.
While FDA is not required to follow the recommendations of AMDAC, they typically do. Should molnupiravir be approved, it would become the first oral treatment for COVID-19.
Source: FDA
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