Pfizer says FDA grants Priority Review for sBLA for Hympavzi

Pfizer (PFE) announced that the U.S. FDA has accepted and granted Priority Review for the company’s supplemental Biologics License Application for Hympavzi to expand the approved indication to include the treatment of hemophilia A or B patients 6 years and older with inhibitors, and pediatric patients 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 inhibitors, or hemophilia B without factor IX inhibitors. The FDA has set a Prescription Drug User Fee Act 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.