(By Balaseshan) Baxter International Inc. (NYSE:BAX) said it has submitted an application for the U.S. Food and Drug Administration's (FDA) approval of hemophilia B therapy.
The company has submitted a biologics license application (BLA) to 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.
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.
In select countries, Baxter currently offers a plasma-derived factor IX treatment, Immunine Factor IX Concentrate (Human), for patients with hemophilia B, which has more than 16 years of patient experience in Europe and Latin America.
In addition, Baxter recently announced a partnership with Chatham Therapeutics, LLC to develop a gene therapy based treatment for hemophilia B. Gene therapy could represent another important first for the community as an innovative potential therapy for hemophilia B treatment.
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. About 25,000 people worldwide, including more than 4,000 in the U.S., have been diagnosed with hemophilia B.
BAX is trading down 0.48% at $58.40 on Tuesday. The stock has been trading between $47.55 and $60.54 for the past 52 weeks.