Pivotal Data Announced for FEIBA NF in Hemophilia Prophylaxis
Baxter announced pivotal Phase 3 study results evaluating the efficacy and safety of routine prophylaxis compared to on-demand treatment of FEIBA NF (Anti-Inhibitor Coagulant Complex) in patients with hemophilia A or B and inhibitors. FEIBA NF is a human plasma fraction with Factor VIII inhibitor bypassing activity.
The Phase III prospective, open label, randomized, multi-center, parallel study investigated the efficacy, safety and health-related quality of life benefits of FEIBA NF prophylactic treatment compared to on-demand treatment in 36 patients with hemophilia A or B and inhibitors over a 12 month period. Results from the study showed a reduced median annual bleed rate from 28.7 during FEIBA NF on-demand treatment to 7.9 during FEIBA NF prophylactic treatment (a 72.5% reduction).
FEIBA NF is indicated for the control of spontaneous bleeding episodes or to cover surgical interventions in hemophilia A and hemophilia B patients with inhibitors.For more information call (800) ANA-DRUG or visit www.baxter.com.