Pfizer Receives FDA Approval for Marstacimab in Hemophilia A and B

Pfizer today announced that the FDA has approved marstacimab for the prevention of bleeding episodes in adults and adolescents 12 years and older with severe hemophilia A or B without inhibitors. The approval was based on results from the Phase 3 BASIS trial, which demonstrated a statistically significant reduction in the annualized bleed rate compared to prior prophylaxis. Marstacimab is a subcutaneous anti-TFPI antibody that restores hemostasis by inhibiting tissue factor pathway inhibitor. The once-weekly subcutaneous injection provides patients with hemophilia a convenient prophylaxis option.