FDA Accepts And Grants Priority Review For Pfizer's sBLA For HYMPAVZI To Expand Approved Indication To Include Treatment Of Hemophilia A Or B Patients; Sets PDUFA Action Date In Q2 2026

• Submission is to expand HYMPAVZI indication to the treatment of hemophilia A or B patients 6 years and older with inhibitors, and pediatric patients (ages 6 to 11) without inhibitors
• If approved, HYMPAVZI would become the first non-factor prophylactic treatment available for children aged 6 to 11 years with hemophilia B

Pfizer Inc. (NYSE:PFE)today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company's supplemental Biologics License Application (sBLA) for HYMPAVZI® (marstacimab) to expand the approved indication to include the treatment of 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. In the U.S., HYMPAVZI is currently approved for the treatment of patients 12 years of age and older with hemophilia A without factor VIII (FVIII) inhibitors, or hemophilia B without factor IX (FIX) inhibitors.

The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in the second quarter of 2026. If approved, HYMPAVZI would offer a combination of bleed protection with a straightforward, once-weekly subcutaneous injection administration, requiring minimal preparation and no routine treatment-related lab monitoring for these difficult-to-treat patient populations.