Pfizer (PFE, Financial) has announced that the European Commission has approved Hympavzi (marstacimab) for the treatment of severe hemophilia A or B. This approval is for patients aged 12 and older, weighing at least 35 kilograms, who do not have FVIII or FIX inhibitors.
Hympavzi is notable for being the first anti-tissue factor pathway inhibitor (anti-TFPI) approved in the EU. It is also the first hemophilia medication in the EU that can be administered via a pre-filled auto-injector pen. This subcutaneous treatment requires minimal preparation and is administered once weekly. The medication had already received approval from the FDA in October.