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Aptevo Therapeutics Doses First Patient in IXINITY Clinical Trial for Potential Pediatric Label Expansion
Clinical Data Intended to be Used to Support Pediatric Label Expansion for IXINITY Approximately 1/3 of U.S. Hemophilia B Patients are Under Twelve Years of
About this update from Aptevo Therapeutics Inc.
[{"type":"text","content":"Clinical Data Intended to be Used to Support Pediatric Label Expansion for IXINITY Approximately 1/3 of U.S. Hemophilia B Patients are Under Twelve Years of Age; Pediatric Approval Could Significantly Increase the Addressable Patient Population for IXINITYSEATTLE, WA / ACCESSWIRE / January 30, 2020 / Aptevo Therapeutics Inc. (NASDAQ:APVO), a biotechnology company focused on developing novel oncology and hematology therapeutics, today announced that the company has begun dosing patients in a Phase 4 clinical trial to evaluate the safety and efficacy of IXINITY® [Coagulation Factor IX (Recombinant)] in previously treated patients under 12 years of age with hemophilia B.Launched in the United States in 2015 and wholly-owned by Aptevo, IXINITY is an intravenous recombinant factor IX therapeutic for use in people 12 years of age or older with hemophilia B, a hereditary bleeding disorder characterized by a deficiency of clotting factor IX in the blood. According to the World Federation of Hemophilia ‘Report on the Annual Global Survey 2017' approximately 34% of people treated for hemophilia B in the U.S. are 12 years of age or younger.1\"Initiation of the clinical study of IXINITY in younger patients is the next step expanding treatment options for patients with hemophilia B,\" said Mike Adelman, Senior Vice President, Commercial Operations. \"This study, together with the introduction of a 3000 IU range vial last year, reinforces that Aptevo is continuing to execute on new initiatives that will support further growth of IXINITY. According to industry estimates, the addressable U.S. patient population for IXINITY could increase by up to one-third if we are successful in obtaining a pediatric label expansion in the U.S.\"A subset of clinical data from the Phase 3 program to support the registration of IXINITY in the U.S. was previously presented by Aptevo. This analysis was drawn from pooled data of 2 prospective, multi-center, non-randomized, open-label studies of 12 children with hemophilia B under the age of 12 years. The data showed that IXINITY appeared to be well tolerated in this pilot subject population and had results comparable to those from the overall patient population studied in the Phase 3 clinical trial of IXINITY.The current Phase 4 clinical trial is expected to enroll up to 22 patients to evaluate the safety, efficacy...