Drug major Pfizer Inc. (PFE) announced Wednesday that the European Commission or EC has granted marketing authorization for HYMPAVZI (marstacimab) to treat adults and adolescents with severe Hemophilia A or B without inhibitors.
The approval is to treat the routine prophylaxis of bleeding episodes in patients 12 years of age and older weighing at least 35 kg with severe hemophilia A without FIX inhibitors.
Hemophilia is a family of rare genetic blood diseases caused by a clotting factor deficiency.
HYMPAVZI offers a subcutaneous treatment option with a once-weekly dosing schedule and minimal preparation required for each individual administration.
The marketing authorization is based on results from the pivotal Phase 3 BASIS study (NCT03938792), demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors.
The company noted that HYMPAVZI is the first and only anti-tissue factor pathway inhibitor or anti-TFPI approved in the European Union for the treatment of hemophilia A or B. It is also the first hemophilia medicine approved in the EU to be administered via a pre-filled, auto-injector pen.
Pfizer said the marketing authorization is valid in all 27 EU member states, as well as in Iceland, Liechtenstein, and Norway. The EC approval follows the regulatory approval of HYMPAVZI in the United States in October.
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