The submission was based on a global, prospective, multi-center Phase 2/3 open label clinical trial that examined the efficacy and safety of OBI-1 for the treatment of serious bleeds in adults with acquired hemophilia A. Patients (N=18) who presented with a serious bleed were treated with an initial dose of OBI-1, followed by additional doses based on their personal profiles, including clinical evaluations and target factor VIII activity levels. The primary efficacy endpoint 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 with the use of OBI-1 effective in 14 patients and partially effective in 4 patients in the first 24 hours, based on clinical assessment and FVIII activity levels.
Previously the FDA had granted OBI-1 Orphan Drug designation and Fast Track designation for acquired hemophilia A.
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