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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER