Pfizer Submits BLA to FDA for Marstacimab in Hemophilia A and B

Pfizer today announced the submission of a Biologics License Application (BLA) to the FDA for marstacimab for the prevention of bleeding episodes in patients with severe hemophilia A or B without inhibitors. The submission is based on positive 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. If approved, marstacimab would provide patients with hemophilia a new once-weekly subcutaneous prophylaxis option.