EC approval for Pfizer’s Hympavzi

The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer (NYSE: PFE).

The drug is approved for the routine prophylaxis of bleeding episodes in patients 12 years of age and older weighing at least 35 kg with severe hemophilia A (congenital factor VIII [FVIII] deficiency, FVIII <1%) without FVIII inhibitors or severe hemophilia B (congenital factor IX [FIX] deficiency, FIX <1%) without FIX inhibitors.

Hympavzi is the first and only anti-tissue factor pathway inhibitor (anti-TFPI) approved in the European Union (EU) for the treatment of hemophilia A or B and the first hemophilia medicine approved in the EU to be administered via a pre-filled, auto-injector pen. Hympavzi offers a subcutaneous treatment option with a once-weekly dosing schedule and minimal preparation required for each individual administration.