FDA sets late 2024 de­ci­sion dead­line for Pfiz­er’s 'pan-he­mo­phil­i­a' drug: #ASH23

SAN DIEGO — The FDA is ex­pect­ed to de­cide whether to ap­prove Pfiz­er’s he­mo­phil­ia A and B an­ti­body in the fourth quar­ter of 2024, the New York phar­ma an­nounced Mon­day af­ter­noon. An ap­proval of marstacimab could kick­start Pfiz­er’s chal­lenge to Roche’s block­buster Hem­li­bra in he­mo­phil­ia A and pro­vide a first week­ly in­jec­tion op­tion for he­mo­phil­ia B.

In a clin­i­cal tri­al, 116 he­mo­phil­ia pa­tients re­ceived once-a-week treat­ment with Pfiz­er’s an­ti­body marstacimab. Those who had pre­vi­ous­ly been re­ceiv­ing reg­u­lar in­fu­sions of fac­tor VI­II or IX — the clot­ting fac­tors that pa­tients with he­mo­phil­ia A and B are miss­ing — saw their an­nu­al rate of bleed­ing events drop by 35% on marstacimab. For the pa­tients who had pre­vi­ous­ly been get­ting on-de­mand in­fu­sions, an­nu­al bleed­ing events fell by 92% on marstacimab, which is de­liv­ered via a pre-filled pen.

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