Thank you to Elaine Benoit, Precision BioLogic Inc., for this heads-up. Takeda Pharmaceuticals U.S.A. Inc. announced it has discontinued the production of therapeutics HEMOFIL M® and RECOMBINATE®. HEMOFIL M, developed by Baxter Hyland, is a human plasma-derived factor concentrate approved by the US FDA in 1966 for on-demand hemophilia A therapy. RECOMBINATE, also developed by Baxter Hyland, is the first synthetic concentrate. RECOMBINATE preparation relies on sterile human serum albumin (HSA) and the presence of HSA in both therapeutics carries the theoretical risk of viral transfer.
Also, on 25 February 2025, Pfizer Inc. announced it would discontinue the Hemophilia B gene transfer therapy Beqvez® due to a lack of demand and the broadening availability of factor bypassing and rebalancing therapies marstacimab (Hympavzi®), concizumab (Alhemo®), and fitusiran, whose developer Sanofi anticipates US FDA approval on 28 March 2025.
Mar 21 2025
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