FEIBA Approved for Prophylactic Treatment of Hemophilia Patients
Phase III data show 72% reduction in annual bleed rate (December 19)
The FDA has given the nod to FEIBA (anti-inhibitor coagulant complex, Baxter International Inc.), the first 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 (ie, antibodies produced by the body’s immune system in response to factor-replacement therapy).
Inhibitor development is considered one of the most serious complications associated with the treatment of hemophilia. As many as one-third of previously untreated patients with severe or moderately severe hemophilia A are at risk for developing inhibitors. The presence of an inhibitor makes response to treatment more challenging, and patients with inhibitors have an increased risk of developing complications.
The FDA’s approval is based on data from a pivotal phase III study, FEIBA PROOF, in which treatment with a FEIBA prophylactic regimen achieved a 72% reduction in the median annual bleed rate (ABR) compared with treatment with an on-demand regimen. In the intent-to-treat (ITT) analysis, three (18%) of the 17 adult patients in the prophylactic arm reported no bleeding episodes.
The most frequently reported adverse reactions in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting. The serious adverse reactions seen with FEIBA included hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism, and deep vein thrombosis.
FEIBA is an anti-inhibitor coagulant complex indicated for use in patients with hemophilia A and B with inhibitors for the control and prevention of bleeding episodes, for perioperative management, and for routine prophylaxis to prevent or reduce the frequency of bleeding episodes. FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX.
Source: Baxter; December 19, 2013.