The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the granting of marketing authorization for Hympavzi (marstacimab) to treat bleeding episodes in individuals aged 12 years and older with severe hemophilia A and B. The drug is pending final approval from the European Commission after receiving orphan status in December 2023. The drug works by increasing thrombin generation to promote hemostasis. A phase 3 clinical trial called BASIS showed that Hympavzi reduced bleeding rates compared to standard care. The drug was well tolerated with common adverse events including COVID-19 and injection site reactions. Hympavzi will be available as a 150-mg injection for patients with severe hemophilia A or B without inhibitors.
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Hympavzi Recommended for Approval in Europe for Severe Hemophilia A, B
