FDA and EMA accept marstacimab filings for hemophilia A and B treatment

The US Food and Drug Administration (FDA) has accepted Pfizer’s (NYSE: PFE) Biologics License Application (BLA) for its anti-tissue factor pathway inhibitor (anti-TFPI) candidate marstacimab for individuals living with hemophilia A or hemophilia B without inhibitors to Factor VIII (FVIII) or Factor IX (FIX).

Additionally, the US pharm giant said, the European marketing authorization application (MAA) for marstacimab also passed validation and is currently under review by the European Medicines Agency (EMA).

These submissions were based on the positive Phase III data presented last weekend at the American Society of Hematology (ASH) annual meeting, which found that marstacimab reduced the annual bleeding rate (ABR) by 35% and 92% compared to routine prophylaxis and on-demand treatment in patients with hemophilia A and B without inhibitors, respectively.