Ahead of ad­comm for full ap­proval, FDA es­ti­mates Pfiz­er's Covid pill could save 1,500 lives per week

Ahead of Thurs­day’s meet­ing of the FDA’s An­timi­cro­bial Drugs Ad­vi­so­ry Com­mit­tee, which will de­cide whether to flip Pfiz­er’s block­buster Covid-19 pill from an EUA to a full ap­proval, the agency re­leased a gen­er­al­ly pos­i­tive rec­om­men­da­tion but not­ed the sig­nif­i­cant risks from drug-drug in­ter­ac­tions.

While not­ing an ab­solute risk re­duc­tion with Paxlovid for the hos­pi­tal­iza­tion/death end­point of about 1% to 2% for a pa­tient with base­line SARS-CoV-2 im­mu­ni­ty, on the pop­u­la­tion lev­el, FDA says there “re­mains a large ben­e­fit.” The agency al­so notes that Pfiz­er’s piv­otal clin­i­cal tri­al re­sults sup­port the ef­fi­ca­cy of Paxlovid for treat­ing mild-to-mod­er­ate Covid in high-risk adults re­gard­less of vac­ci­na­tion sta­tus or pri­or in­fec­tion.

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