FDA, EMA to Review Hemophilia Treatment | ASH Clinical News | American Society of Hematology
The U.S. Food and Drug Administration (FDA) accepted Pfizer’s Biologics License Application for marstacimab as treatment for hemophilia A or hemophilia B in patients without inhibitors to factor VIII or factor IX. The Prescription Drug User Fee Act action date is set for the fourth quarter of 2024. Marstacimab is a human monoclonal immunoglobulin G isotype. It works by targeting the Kunitz 2 domain of tissue factor pathway inhibitor. The treatment is being investigated as a prophylactic treatment to