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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