Baxter files FEIBA NF BLA with FDA for prophylactic treatment of hemophilia A or B

Published on February 26, 2013 at 11:55 PM · No Comments

Baxter International Inc. (NYSE:BAX) today announced that the company has submitted a biologics license application (BLA) supplement to the U.S. Food and Drug Administration (FDA) for the approval of prophylaxis treatment of FEIBA NF [Anti-Inhibitor Coagulant Complex], Nanofiltered and Vapor Heated, in patients with hemophilia A or B and inhibitors.

As many as one third of people with hemophilia develop an inhibitor to factor replacement used to treat or prevent bleeding episodes. The presence of an inhibitor makes response to treatment more challenging, and patients with inhibitors have an increased risk of developing complications such as joint damage. It is estimated that approximately 17,000 people in the U.S. have been diagnosed with hemophilia A or B.

''This regulatory submission helps fulfill Baxter's commitment to advancing care for patients who have developed inhibitors, a serious and sometimes life-threatening complication for those with hemophilia A or B,'' said Prof. Hartmut J. Ehrlich, M.D., vice president of global research and development in Baxter's BioScience business. ''Baxter has been supporting innovations in care for the hemophilia community for more than 60 years, and our work continues not only with FEIBA, but also with other treatments we are actively developing.''

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