Baxter files OB-1 at FDA for Haemophilia A

Baxter International Inc. announced that the company has submitted a biologics license application (BLA) to the FDA for the approval of OBI-1, a recombinant antihaemophilic porcine sequence factor VIII, in patients with acquired Haemophilia A. Phase II/III data supporting the submission were presented at the American Society of Hematology's (ASH) 55th Annual Meeting in New Orleans, LA

The global, prospective, multi-center phase II/III open label clinical trial examined the efficacy and safety of OBI-1 in the treatment of serious bleeds in adults with acquired Haemophilia A. Patients (N=18) who presented with a serious bleed were treated with an initial dose of OBI-1 (200 units per kilogram), followed by additional doses based on their personal profiles, including clinical evaluations and target factor VIII activity levels. The primary efficacy endpoint of the study was defined by clinical assessment as effective or partially effective control of bleeding and FVIII activity levels at 24 hours after initiation of OBI-1 therapy. All patients in the study responded positively (14 effective / 4 partially effective) in the first 24 hours, based on clinical assessment and FVIII activity levels. No treatment-related serious adverse events were reported in the study. Non-serious mild adverse events related to treatment were reported in two of 18 patients (11.1%). These two patients developed anti-porcine inhibitors to OBI-1.