Pfizer's BeneFIX reduces bleeding rates in Ph III study

US pharma giant Pfizer (NYSE: PFE) today released positive results of a Phase III study comparing a prophylaxis regimen of BeneFIXCoagulation Factor IX (recombinant) 100 IU/kg once-weekly to on-demand treatment in people with moderately severe to severe hemophilia B.

The top-line results of the study showed that the primary study endpoint was met and hemophilia B patients taking once-weekly BeneFIX (100 IU/Kg) showed a statistically significant reduction in the annualized bleeding rate (ABR).

In the study, the median ABR value, a commonly used measure of efficacy for prophylaxis regimens in hemophilia, was 2.0 for the prophylaxis regimen, compared to 33.6 for the on-demand regimen, representing a 94% decrease in bleeding rates. The mean ABR value was 3.6 for the prophylaxis period, compared to 32.9 for the on-demand treatment, which represents a reduction of 89%.