Baxter International Inc. today announced that the company has submitted a biologics license application (BLA) to the United States Food and Drug Administration (FDA) for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)].

"The evidence from our late-stage controlled trial showcases that BAX 855 could become an important new treatment option for people with hemophilia A, expanding on more than a decade of experience with ADVATE," said John Orloff, M.D., vice president and global head of research and development for Baxter BioScience. "BAX 855 represents our continued commitment to developing valuable new options for the hemophilia community that address the needs of patients around the world."

The submission is based on positive results from a prospective, global, multi-center, open-label, two-arm Phase 3 study of 137 previously treated patients (PTP). The results demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding episodes and routine prophylaxis for patients who were 12 years or older.

For more details, go to: http://www.baxter.com/press_room/press_releases/2014/12_01_14_bax855.html