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Baxter Receives FDA Approval for FEIBA for Prophylactic Treatment in Inhibitor Patients

January 1, 2014

The US Food and Drug Administration (FDA) has approved FEIBA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B who have developed inhibitors. FEIBA is a plasma-derived therapy manufactured by Baxter HealthCare. For more than 35 years it has been approved for on-demand use. Baxter announced the approval in a December 2013 press release. FEIBA is a so-called "bypassing agent," a factor product containing several other clotting proteins, enabling it to circumvent or "bypass" the need for the deficient clotting factors VIII or IX while still ensuring adequate clot formation.

The approval is based on data from a Phase 3 study called FEIBA PROOF, in which treatment with a FEIBA prophylactic regimen showed a 72% reduction in median annual bleed rate compared to treatment with an on-demand regimen. Three of the 17 adult patients (18%) in the prophylactic arm of the study reported no bleeds. The most common side effects were anemia, diarrhea, joint bleeds, hepatitis B surface antibody positive, nausea and vomiting.

"The PROOF study demonstrated that a prophylactic regimen with FEIBA can significantly reduce the rate of bleeding episodes, as compared to an on-demand regimen, in hemophilia patients with inhibitors. This is important among these patients who often have difficult-to-treat bleeds and are at risk of additional complications," said Steven Pipe, MD, Director, Division of Pediatric Hematology and Oncology, at the C.S. Mott Children's Hospital at the University of Michigan. "This FDA approval of a prophylactic regimen should change the way physicians think about managing hemophilia with inhibitors, validating FEIBA prophylaxis as an effective new option to treat their patients."


Source: Baxter press release dated December 19, 2013