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Baxter International Inc Submits Application For FDA Approval Of Recombinant Factor IX for Treatment Of Hemophilia B


Tuesday, 4 Sep 2012 09:00am EDT 

Baxter International Inc announced that the Company has submitted a biologics license application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for approval of BAX 326, a recombinant factor IX (rFIX) protein being investigated for the treatment and prophylaxis of bleeding episodes for patients over 12 years of age with hemophilia B. Hemophilia B, also known as Christmas disease, is the second most common type of hemophilia and results from insufficient amounts of clotting factor IX, a naturally occurring protein in blood that helps to control bleeding. Approximately 25,000 people worldwide, including more than 4,000 in the U.S., have been diagnosed with hemophilia B. The BLA filing is based on results from a global Phase III 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. Baxter expects to file its application for BAX 326 in Europe in 2013. 

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