Baxter submits FDA applications for hemophilia A drug OBI-1 and for pediatric indication of Rixubis

USA-based Baxter International (NYSE:BAX) has submitted a biologics license application (BLA) to the US Food and Drug Administration for the approval of OBI-1, a recombinant antihemophilic porcine sequence factor VIII, in patients with acquired hemophilia A.

The company presented supporting Phase II and III data at the American Society of Hematology's 55th Annual Meeting. The global, prospective, multicenter 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 hemophilia A. Patients 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 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-1therapy. 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.

Rebecca Kruse-Jarres, associate professor of medicine and pediatrics, Tulane University and past National Hemophilia Foundation-Baxter Fellow, said: “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. 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."