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.
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)