Pfizer (PFE) announced on Friday that the U.S. Food and Drug Administration granted priority review for a marketing application seeking a label expansion for its hemophilia therapy, Hympavzi.
The New York-based pharma giant had submitted its supplemental Biologics License Application in an attempt to expand the Hympavzi label to include patients aged six years and older with hemophilia A or B.
The once-weekly subcutaneous injection is currently marketed in the U.S. for patients aged 12 years and older with hemophilia A without factor VIII (FVIII) inhibitors or hemophilia B without factor IX (FIX) inhibitors.
The sBLA is aimed at expanding its approved indication for use with inhibitors in patients aged six years and older with hemophilia A or B and for use without inhibitors in children aged 6–11 years. The FDA has assigned a target action date in Q2 2026 to arrive at a decision.