On 11 October 2024, Hympavzi (marstacimab-hncq), a human monoclonal antibody targeting “tissue factor pathway inhibitor” received US FDA’s approval as a new drug for prevention of bleeding episodes in individuals with hemophilia A or hemophilia B.
Earlier, on 19 September 2024, Hympavzi was granted marketing authorisation by European Medicine Agency (EMA) for prophylaxis of bleeding episodes in patients with severe hemophilia A or B.
Hemophilia A is an inherited bleeding disorder caused by a lack of blood clotting factor VIII while hemophilia B is caused by insufficiency of the clotting factor IX. Both the conditions are conventionally treated by replacing missing blood clotting factors by injections.
Hympavzi prevents bleeding episodes by a different process. It targets the naturally occurring anticoagulation protein called “tissue factor pathway inhibitor” and reduces its anticoagulation activity thereby increasing the amount of thrombin.
The new drug provides a new treatment option to the patients. This is first, non-factor and once-weekly treatment for hemophilia B.
FDA’s approval of Hympavzi is based on satisfactory results from the phase 3 multicentre clinical trial that evaluated its safety and efficacy in adolescent and adult participants ages 12 to <75 years with severe hemophilia A or moderately severe to severe hemophilia B.
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Sources:
- FDA News release – FDA Approves New Treatment for Hemophilia A or B. Posted on 11 October 2024. Available at https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-hemophilia-or-b
- EMA. Hympavzi – Marstacimab. Available at https://www.ema.europa.eu/en/medicines/human/EPAR/hympavzi
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