Baxter Seeks Approval for Hemophilia A Drug

December 2, 2014

Baxter International has submitted a biologics license application to the FDA for its investigational, extended half-life recombinant factor VIII treatment for hemophilia A based on antihemophilic factor.

Baxter International has submitted a biologics license application to the FDA for its investigational, extended half-life recombinant factor VIII treatment for hemophilia A based on antihemophilic factor (recombinant) (ADVATE).

A study of the drug known as BAX 855 among more than 130 previously treated patients showed promise in preventing bleeding episodes, according to a press release from Baxter.

A twice-weekly prophylactic regimen resulted in a 95% reduction in median annualized bleed rate compared with on-demand treatment, according to Baxter. Beyond prevention, BAX 855 showed an aptitude in treating bleeding episodes; 96% of these episodes were controlled with 1 or 2 infusions.

Three patients reported experiencing headaches, but no other adverse side effects were reported.

“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, MD, vice president and global head of research and development for Baxter BioScience, in a press release. “BAX 855 represents our continued commitment to developing valuable new options for the hemophilia community that address the needs of patients around the world.”

A phase 3 study of previously treated patients under the age of 12 with severe hemophilia A is ongoing, according to Baxter.