Biopharmaceutical company Pfizer Inc (NYSE: PFE) announced on Wednesday that it has received European Commission approval for HYMPAVZI (marstacimab) as a once-weekly treatment for severe hemophilia A and B in patients aged 12 and older without inhibitors. This marks the first European Union-approved anti-tissue factor pathway inhibitor (anti-TFPI) therapy for these conditions, administered via a pre-filled auto-injector pen or syringe.

The approval is supported by Phase 3 BASIS study data, which demonstrated HYMPAVZI's superiority over standard prophylaxis, reducing annualized bleeding rates by 35%. Safety profiles were consistent with prior studies, with injection site reactions, headache, pruritus, and hypertension as the most common adverse effects.

Hemophilia, a rare genetic blood disorder impacting over 800,000 globally, impairs blood clotting and causes recurrent bleeding episodes. HYMPAVZI offers a more convenient alternative to intravenous factor replacement therapies, addressing key treatment adherence challenges.

This authorisation applies across all EU member states, Iceland, Liechtenstein and Norway, following the drug's US approval in October. Pfizer's broader hemophilia program includes advancements in gene therapies for hemophilia A and B, further solidifying its leadership in addressing unmet needs in bleeding disorders.