The U.S. Food and Drug Administration (FDA) has approved Hympavzi, a monoclonal antibody drug containing marstacimab, for routine bleeding prevention in patients with hemophilia A and B over the age of 12. Unlike the standard approach of replacing the missing clotting factor, marstacimab reduces the amount and activity of the anticoagulant protein tissue factor inhibitor. This increases the production of thrombin, an enzyme that plays a crucial role in blood clotting. The approval was announced on the agency's website.
The approval of Himpavzi is based on the results of an open-label, multicenter study involving 116 patients with severe hemophilia A or severe hemophilia B. The results showed that the annual bleeding rate in the prophylaxis group was nearly 35 percent lower than in the control group. The most common side effects were injection site reactions, headache, and itching.
