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Baxter Submits Application For FDA Approval Of OBI-1 For Patients With Acquired Hemophilia A

Baxter International Inc. (NYSE:BAX) today announced that the company has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of OBI-1, a recombinant antihemophilic porcine sequence factor VIII, in patients with acquired hemophilia A. Phase 2/3 data supporting the submission were presented at the American Society of Hematology’s (ASH) 55 th Annual Meeting in New Orleans, LA.

''The data we presented today at ASH showed that all patients in the trial experienced a positive response to treatment with OBI-1 within 24 hours of initiation of care,'' said Rebecca Kruse-Jarres, M.D., MPH, Associate Professor of Medicine and Pediatrics, Tulane University and past National Hemophilia Foundation-Baxter Fellow. ''These are promising results for a patient population that would benefit from a treatment option that provides temporary FVIII replacement and measurement of FVIII levels.''

The global, prospective, multi-center phase 2/3 open label clinical trial examined the efficacy and safety of OBI-1 in 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 (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.

OBI-1 has been granted orphan-drug designation for acquired hemophilia A by the FDA. Orphan-drug designation is given to drugs and biologics intended to treat rare diseases, typically those that impact less than 200,000 Americans annually. The application has also been granted a fast-track designation, which is intended to expedite the review process of drug candidates with the potential to fulfill an unmet medical need. Baxter acquired OBI-1 in March from Inspiration BioPharmaceuticals, Inc. and Ipsen Pharma S.A.S.

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