Posted by Michael Wonder on 06 Feb 2026
FDA grants priority review for Hympavzi (marstacimab) sBLA for the treatment of two haemophilia A or B patient populations with significant medical need
6 February 2026 - Pfizer today announced that the US FDA has accepted and granted priority review for the company’s supplemental biologics license application for Hympavzi (marstacimab) to expand the approved indication to include the treatment of haemophilia A or B patients 6 years and older with inhibitors, and paediatric patients (ages 6 to 11) with haemophilia A or B without inhibitors.
The FDA has set a PDUFA action date in the second quarter of 2026.
