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Medexus Study Supports Efficacy and Safety of IXINITY in Pediatric Patients with Severe or Moderately Severe Hemophilia B
Poster presentation at National Hemophilia Foundation (NHF) Bleeding Disorders Conference 2023 hi...
About this update from Medexus Pharmaceuticals Inc.
[{"type":"text","content":"Medexus Study Supports Efficacy and Safety of IXINITY in Pediatric Patients with Severe or Moderately Severe Hemophilia BPoster presentation at National Hemophilia Foundation (NHF) Bleeding Disorders Conference 2023 highlights effective prophylaxis, control of bleeding episodes, and consistent safety profilePhase 3/4 data presentation follows FDA acceptance for review of IXINITY® supplemental Biological License Application for pediatric patientsToronto, Ontario and Chicago, Illinois--(Newsfile Corp. - August 17, 2023) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced the presentation of data from a Phase 3/4 study that evaluated the pharmacokinetics (PK), safety, and efficacy of IXINITY, an intravenous recombinant factor IX therapeutic, as a prophylactic treatment in previously treated pediatric patients under 12 years of age with severe or moderately severe hemophilia B, a hereditary bleeding disorder characterized by a deficiency of clotting factor IX in the blood.In a poster presentation at the National Hemophilia Foundation (NHF) Bleeding Disorders Conference 2023 in National Harbor, Maryland, researchers reported that prophylaxis with IXINITY was associated with low annualized bleeding rates (ABRs), effective control of bleeding episodes, consistent PK, and a consistent safety profile. See \"About the study\" below for additional information about the study's methods, results, and conclusions. IXINITY is currently approved for use in patients 12 years of age or older with hemophilia B.\"This study demonstrated the efficacy of IXINITY in the prevention and control of bleeding episodes in pediatric subjects while providing a favorable safety profile,\" commented Johnny Mahlangu, BSc, MBBCh, MMed, FCPath, the study's principal investigator. \"The results bolster the overall utility of this recombinant factor IX agent in the treatment of individuals with hemophilia B.\"\"The data presented at BDC 2023 add to the growing body of evidence of IXINITY's efficacy and safety,\" said Mark Fosdal, DHSc, PA-C, Director of Scientific Communications at Medexus and a coauthor of the study. \"Subject to FDA approval of the pediatric indication, the accumulated data should give clinicians greater confidence in administering IXINITY to maintain reliably high factor IX levels long-term, for all patients of all ages with ...