Pfizer Marstacimab regulatory submissions for treatment of Hemophilia A and B accepted by USFDA, EMA
The submissions for marstacimab are based on efficacy and safety data from the Phase 3 BASIS trial.;
New York: Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s 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). The European marketing authorization application (MAA) for marstacimab also passed validation and is currently under review by the European Medicines Agency (EMA).
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in the fourth quarter of 2024, and a decision from the European Commission is anticipated by the first quarter of 2025. "If approved in the U.S. and EU, marstacimab is expected to become the first once-weekly subcutaneous treatment for people living with haemophilia B and the first treatment administered as a flat dose for people living with haemophilia A or B," the Company stated in a release.
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