Baxter’s Feiba gains FDA approval for prophylactic treatment of hemophilia A and B

US drugmaker Baxter International (NYSE: BAX) has received approval from the US Food and Drug Administration for its 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 hemophilia A or B who have developed inhibitors.

Inhibitor development is considered one of the most serious complications associated with hemophilia treatment today. As many as one-third of previously untreated patients with severe or moderately severe hemophilia 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.

Pivotal Ph III data showed 72% reduction in median annual bleed rate