Medexus Pharmaceuticals announced that the US Food and Drug Administration (FDA) recently approved Medexus's supplemental Biologics License Application (sBLA) for IXINITY® [coagulation factor IX (recombinant] for the on-demand, prophylactic, and perioperative treatment of pediatric patients under 12 years of age with hemophilia B. IXINITY®, an intravenous recombinant factor IX therapeutic, is now approved for use in all patients with hemophilia B, a hereditary bleeding disorder characterized by a deficiency of clotting factor IX in the blood. The sBLA and expanded indication for IXINITY® are based on results from a Phase 3/4 study that evaluated the pharmacokinetics (PK), safety, and efficacy of IXINITY® as a prophylactic treatment in previously treated pediatric patients under 12 years of age with severe or moderately severe hemophilia B. The study demonstrated that prophylaxis with IXINITY® was associated with low annualized bleeding rates, effective control of bleeding episodes, consistent PK, and a consistent safety profile.
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