FDA approves FEIBA to reduce bleeding in Haemophilia patients with inhibitors-Baxter

Baxter International Inc. announced that the FDA granted approval on 19 December 2013 of Baxter's FEIBA [ Anti-Inhibitor Coagulant Complex ], the first and only FDA -approved treatment for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with Haemophilia A or B who have developed inhibitors. Inhibitor development is considered one of the most serious complications associated with Haemophilia treatment today. As many as one-third of previously untreated patients with severe or moderately severe Haemophilia A are at risk for developing inhibitors, which are antibodies produced by the body's immune system in response to factor replacement treatment. The presence of an inhibitor makes response to treatment more challenging, and patients with inhibitors have an increased risk of developing complications.

The approval is based on data from a pivotal Phase III study, known as FEIBA PROOF, in which treatment with a FEIBA prophylactic regimen showed a 72 percent reduction in median annual bleed rate (ABR) compared to treatment with an on-demand regimen. In the intent-to-treat (ITT) analysis, three of the 17 (18%) adult patients in the prophylactic arm reported no bleeding episodes.