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FDA Accepts for Review Medexus's IXINITY Supplemental Biological License Application for Pediatric Patients
Expanded indication would cover patients 12 years of age or younger, a population that comprises ...
About this update from Medexus Pharmaceuticals Inc.
[{"type":"text","content":"FDA Accepts for Review Medexus's IXINITY Supplemental Biological License Application for Pediatric PatientsExpanded indication would cover patients 12 years of age or younger, a population that comprises approximately one in three patients treated for hemophilia B in the United StatesToronto, Ontario and Chicago, Illinois--(Newsfile Corp. - June 15, 2023) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced that the US Food and Drug Administration (FDA) recently accepted for review Medexus's supplemental Biological 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 - a hereditary bleeding disorder characterized by a deficiency of clotting factor IX in the blood. IXINITY®, an intravenous recombinant factor IX therapeutic, is currently approved for use in patients 12 years of age or older with hemophilia B.\"Approximately one third of patients treated for hemophilia B in the United States are children 13 years of age and under,\" said Ken d'Entremont, Chief Executive Officer of Medexus. \"Risk of bleeding events can severely limit these children's daily activities. The FDA's commitment to review our sBLA brings us a step closer to making IXINITY® a viable factor IX treatment option for this important population.\"* Source: World Federation of Hemophilia Report on the Annual Global Survey 2021; www1.wfh.org/publications/files/pdf-2324.pdf (accessed June 13, 2023).About IXINITY®IXINITY® [coagulation factor IX (recombinant)] Lyophilized Powder for Solution for Intravenous Injection is a coagulation factor IX (recombinant) indicated in adults and children ≥12 years of age with hemophilia B for on-demand treatment and control of bleeding episodes, perioperative management, and for routine prophylaxis to reduce the frequency of bleeding episodes.The most common adverse reaction observed in >2% of patients in clinical trials was headache. For more information about IXINITY®, including important safety information, see the full prescribing information, which is available on the product's website at: www.ixinity.com.IXINITY® is approved by the FDA for sale and use in the United States only and is not intended for export outside the U...