(News Bulletin 247) – Pfizer announced yesterday that the United States Food and Drug Administration (FDA) Antimicrobial Drug Advisory Committee (AMDAC) voted 16 to 1 that the data supports the safety and efficacy of PAXLOVID for the treatment of COVID-19 in adult patients who are at high risk of progression to severe disease.
AMDAC’s vote, while non-binding, will be considered by the FDA when making its decision regarding the potential approval of PAXLOVID.
‘ We believe it is essential that adults at high risk of progressing to a severe form of COVID-19 have access to safe and effective treatment options, such as PAXLOVID, in order to avoid avoidable hospitalizations and deaths. ‘, said James Rusnak, senior vice president at Pfizer.
AMDAC based its vote on all of the scientific and factual evidence provided by Pfizer, including safety and efficacy data from the Evaluation of Protease Inhibition for COVID-19 (EPIC) clinical development program.
The Prescription Drug User Fee Act (PDUFA) action date for an FDA decision is May 2023.
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