BAX 855 meets in Phase III hemophilia A trial

Baxter International Inc. (NYSE:BAX) said BAX 855 met the primary endpoint of reducing the annualized bleeding rate (ABR) of patients with hemophilia A when administered as a prophylaxis compared to on demand in the Phase III PROLONG-ATE trial. In the global, open-label, 138-patient study, BAX 855 reduced median ABR by 95% in patients 12 years or older with previously treated severe hemophilia A in the twice-weekly prophylaxis group compared to the on-demand group (1.9 vs 41.5, p=0.0001).

Baxter expects to submit a BLA to FDA for BAX 855 before year end and an MAA to EMA once it completes a Phase III pediatric study that is expected to start shortly. ...