PHARMA/BIOTECH UPDATE: Baxter Receives FDA Approval of FEIBA for Hemophiliacs with Inhibitors

Baxter International has received approval from the United States Food and Drug Administration (FDA) of FEIBA, an anti-inhibitor coagulant complex.  FEIBA is the only FDA-approved prophylactic treatment to prevent or reduce the occurrence of bleeding episodes in patients with hemophilia A OR B who have developed inhibitors.

The FDA’s approval was based on a Phase III study known as PROOF, in which treatment with a FEIBA prophylactic regimen showed a 72 percent reduction in annual bleed rate when contrasted against an on-demand treatment regimen.  Promisingly, 18% of adult patients in the prophy group reported zero bleeding episodes.  Commonly noted side effects (observed in less than 5% of prophy test subjects) were anemia, diarrhea, hemarthrosis, hepatitis B surface anitbody positive, nausea, and vomiting.  Serious adverse reactions include hypersensativity and thrombembolic events (ie. stroke, pulmonary embolism, and deep vein thrombosis).

“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, M.D., Director, Division of Pediatric Hematology and Oncology, at the C.S. Mott Children’s Hospital at the University of Michigan in a Baxter press release this morning. “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.”

Because as many as 1/3 of all severe or moderately severe Hemophilia A patients are at risk for developing inhibitors (antibodies produced the immune system in response to factor replacement infusions) this development is very exciting news for patients and families that have had to deal with inhibitors on top of their hemophilia.

Photo credit: Baxter International, Inc.

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