Pfizer: Marketing authorization for Hympavzi in the EU

(CercleFinance.com) - Pfizer reports that the European Commission has granted marketing authorization (MA) for Hympavzi (marstacimab) for the treatment of severe hemophilia in adults and adolescents without inhibitors in the European Union.


This marketing authorization covers the systematic prophylaxis of bleeding episodes in patients aged 12 and over weighing at least 35 kg with severe hemophilia A without FVIII inhibitors or severe hemophilia B without FIX inhibitors.

This approval, which follows that in the U.S. in October, is based on a Phase 3 study demonstrating non-inferiority and superiority to routine prophylaxis in eligible patients with inhibitor-free hemophilia A or B.

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