FDA adcomm votes in favor of Pfizer's Covid-19 pill Paxlovid
The FDA’s Antimicrobial Drugs Advisory Committee voted 16-1 that the benefits of Pfizer’s Covid-19 pill Paxlovid outweigh the risks in adults with mild-to-moderate illness.
The vote followed hours of discussion on topics ranging from efficacy in people who have already been vaccinated or infected to drug-drug interactions (DDIs). Pfizer submitted a request to convert its EUA to a full approval back in June, but the FDA extended its review period by three months to consider additional data submitted, the company announced in December. The current PDUFA action date for a decision by the FDA is May 2023.
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