Baxter granted FDA approval for new FEIBA indication

Baxter Healthcare has been granted US Food and Drug Administration (FDA) approval for a new indication of FEIBA (Anti-Inhibitor Coagulant Complex).

This allows physicians to prescribe the drug for routine prophylaxis of haemophilia A and B patients who have developed inhibitors, making it the first FDA-approved treatment of its kind.

The FDA's decision was based on a Phase III clinical trial called FEIBA PROOF, which found subjects given this course of therapy showed a 72 per cent reduction in median annual bleed rate compared to controls who were prescribed an on-demand treatment regimen.

Of 17 adult patients who received routine prophylaxis, three (18 per cent) reported no bleeding episodes whatsoever.

Some adverse outcomes were reported, including anemia, diarrhea, hemarthrosis hepatitis B surface antibody positive, nausea and vomiting, but less than five per cent of subjects were affected.

According to Steven Pipe, managing director of the Division of Pediatric Hematology and Oncology, CS Mott Children's Hospital, University of Michigan, the FDA approval should "change the way physicians think about managing haemophilia with inhibitors".