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FDA Approves Afstyla (Antihemophilic Factor (Recombinant), Single Chain) for Hemophilia A

Posted 8 Jun 2016 by

KING OF PRUSSIA, Pa. — 26 May 2016 – CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved Afstyla [Antihemophilic Factor (Recombinant), Single Chain], its novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A. Afstyla is the first and only single-chain product for hemophilia A that is specifically designed for long-lasting protection from bleeds with two to three times weekly dosing. In clinical trials, patients undergoing prophylaxis with Afstyla experienced a median annualized spontaneous bleeding rate (AsBR) of 0.00. Once activated, Afstyla is identical to natural factor VIII. Clinical trials of Afstyla demonstrated a strong safety profile with no inhibitors observed. Afstyla is indicated in adults and children with hemophilia A for routine prophylaxis to reduce the frequency of bleeding e ... Read more

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