Baxter announced that it has submitted a biologics license application (BLA) for BAX 326 to the FDA, seeking approval for the treatment and prophylaxis of bleeding episodes for patients >12 years of age with hemophilia B.
The BLA filing is based on results from a global Phase 3 study conducted in 10 countries around the world. The prospective, controlled, multicenter study evaluated the pharmacokinetics, efficacy, safety and immunogenicity of BAX 326 in 73 patients with severe or moderately severe hemophilia B previously treated with other factor IX therapy. The study met its primary objectives and the company plans to present the complete data from the study in late 2012.
BAX 326 is a recombinant factor IX (rFIX) protein.
For more information call (800) ANA-DRUG or visit www.baxter.com.