Baxter reports further positive trial data for new haemophilia drug

Baxter has announced new efficacy and safety data from a phase III pivotal study of BAX 855, its new treatment for haemophilia A.

The investigational extended half-life recombinant factor VIII treatment, which is based on Advate, was previously announced to have met its primary endpoint in this trial, by demonstrating its effectiveness in routine prophylaxis and in controlling and preventing bleeding episodes.

New findings from the study showed that treatment was rated excellent or good for nearly all episodes, while its pharmacokinetics offered a 1.4-1.5-fold extended half-life compared to Advate, with a median infusion interval of 3.6 days.

No patients developed inhibitors to BAX 855, while no treatment-related serious adverse events, including hypersensitivity, were reported.

Dr John Orloff, vice-president and global head of research and development for Baxter BioScience, said: "These pivotal trial results provide evidence to support the efficacy profile of BAX 855 in controlling, preventing or reducing the frequency of bleeding episodes when administered prophylactically twice-weekly."

This comes after the firm applied for European approval of BAY 81-8973, another new treatment for haemophilia A, at the end of last year.