Pfizer's HYMPAVZI Receives FDA Priority Review for Hemophilia A and B Treatment

The FDA has granted Priority Review for Pfizer's supplemental Biologics License Application for HYMPAVZI (marstacimab) to expand its approved indication to include hemophilia A or B patients 6 years and older with inhibitors, and pediatric patients (ages 6 to 11) with hemophilia A or B without inhibitors. The FDA has set a Prescription Drug User Fee Act action date in Q2 2026. If approved, HYMPAVZI would offer a combination of bleed protection with a once-weekly subcutaneous injection administration, requiring minimal preparation and no routine treatment-related lab monitoring.