Phase III results for BAX 326 (Baxter) for Haemophilia B

A Phase I/III prospective, controlled, multicenter study investigated the pharmacokinetics, efficacy and safety of BAX 326 from Baxter, in 73 previously-treated patients with severe or moderately severe Hemophilia B.

Results from the study showed that twice-weekly prophylactic treatment with BAX 326 achieved a median annualized bleed rate of 1.99 with 43 percent of patients experiencing no bleeds. The impact of prophylaxis with BAX 326 also translated into statistically significant improvements in physical health-related quality of life (HRQoL), as measured by improvements in the Bodily Pain and Role-Physical domains in the Short Form Health Survey (SF-36v2) tool. Statistically significant changes were not seen in the other physical health-related domains or the mental health domains. No inhibitors were detected and no cases of anaphylaxis were reported in any patients. Three treatment-related adverse events were reported in 2 of the 73 (2.7%) patients, all of which were mild and transient: dysgeusia (distortion of the sense of taste).