European Commission approves Pfizer’s Hympavzi for the treatment of adults and adolescents with haemophilia A or B with inhibitors

Pfizer

13 May 2026 -  Pfizer today announced that the European Commission has granted marketing authorisation to expand the approved indication for Hympavzi (marstacimab) to include patients 12 years of age and older weighing at least 35 kg with haemophilia A (congenital factor VIII deficiency) with FVIII inhibitors or haemophilia B (congenital factor IX deficiency) with FIX inhibitors.

Approval in patients ages 12 and older based on Phase 3 data demonstrating superior bleed reduction to on demand therapy, with continued benefit observed in open-label extension study.

Read Pfizer press release 

Michael Wonder

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Michael Wonder

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Outcome , Medicine , Europe , Registration