Pfizer's Hympavzi Secures FDA Nod, Offering Novel Once-Weekly Treatment for Hemophilia B

Pfizer’s Hympavzi Secures FDA Nod, Offering Novel Once-Weekly Treatment for Hemophilia B

Pfizer Inc. (NYSE: PFE) has scored a significant win with the US Food and Drug Administration’s (FDA) approval of its drug Hympavzi (marstacimab-hncq) for routine prophylaxis in adults and pediatric patients aged 12 and older with hemophilia A, characterized by a congenital deficiency of factor VIII (FVIII), or hemophilia B, marked by a congenital deficiency of factor IX (FIX), without inhibitors for these factors. This marks a new frontier in hemophilia B treatment, as Hympavzi is the first to necessitate only a once-weekly subcutaneous injection.

Marstacimab-hncq, an anti-tissue factor pathway inhibitor (TFPI), represents a breakthrough in treating both hemophilia A and B patients. Having previously earned fast-track status in the US, this drug demonstrated remarkable efficacy in Phase II clinical studies, reducing the annual bleeding rate by over 75%. This efficacy, coupled with its approval in China, underscores the drug’s potential to transform the treatment landscape for hemophilia patients globally.- Flcube.com

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