Baxter reports positive data from haemophilia drug trial

Baxter has announced positive results from a phase III pivotal clinical trial of an investigational therapy for haemophilia A.

The new study of BAX 855 – an extended half-life recombinant factor VIII treatment based on Advate – met its primary endpoint in reducing annualised bleed rates in the prophylaxis arm, compared to the on-demand arm.

It was able to control and prevent bleeding incidents while enhancing routine prophylaxis and perioperative management for patients who were 12 years or older. A total of 138 adolescent and adult patients with previously-treated haemophilia A were involved in the trial.

BAX 855 uses proprietary PEGylation technology designed to extend the duration of activity of proteins in the body. It will be submitted for US regulatory approval later this year.

Dr John Orloff, vice-president and global head of research and development for Baxter BioScience, said: "The positive results of the BAX 855 study reflect our ongoing, long-term commitment to drive innovation and expand treatment options for patients with haemophilia."

The firm will be hoping it can emulate the success of Advate, which is the most widely-prescribed full-length recombinant FVIII worldwide.