Baxter International Inc said a more potent version of its flagship blood disorder drug Advate met the main goal in a late-stage study.
The experimental drug, BAX 855, was being tested as a preventive therapy and an on-demand treatment in 138 previously treated adolescent and adult hemophilia A patients.
The trial’s main goal was to reduce bleeding rates compared with on-demand treatment.
Hemophilia A, also called classic hemophilia, is a genetic disorder caused by missing or defective factor VIII, a clotting protein.
Patients in the twice-weekly prophylaxis, or preventive, arm of the trial experienced a 95 percent reduction in median yearly bleeding rates compared with those in the on-demand arm, Baxter said.
The company plans to apply for U.S. marketing approval for the drug before the end of the year and said it would begin another late-stage study to test BAX 855 in previously treated patients under the age of 12.
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Baxter raised the forecast for its hemophilia franchise in July, despite the potential for competition from Biogen Idec Inc’s long-acting treatment Eloctate, which the U.S. Food and Drug Administration approved in June.
BAX 855 is an extended-release version of Advate, which was first approved over a decade ago and is currently sold in 64 countries.
The experimental drug uses Nektar Therapeutics’ proprietary technology to extend the duration of activity of proteins in the body.
Deerfield, Illinois-based Baxter’s stock was up about 1.2 percent on the New York Stock Exchange on Thursday. (Reuters)
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