PFE's BeneFIX as prophylaxis bests on-demand in hemophilia B

Pfizer Inc. (NYSE:PFE) said BeneFIX as prophylaxis met the primary endpoint of reducing median annualized bleeding rate (ABR) vs. on-demand treatment with BeneFIX in a Phase III trial evaluating continuous prophylactic treatment of bleeding in patients with hemophilia B (2 vs. 33.6, p<0.0001). Mean ABR was 3.6 for once-weekly prophylaxis treatment vs. 32.9 for on-demand treatment (p<0.0001). The open-label trial enrolled 25 patients for a six-month period of on-demand treatment only with BeneFIX followed by a 12-month period of routine prophylaxis with once-weekly BeneFIX.

BeneFIX is approved in the U.S. and EU for the control, prevention and perioperative management of bleeding episodes in adult and pediatric patients with hemophilia B. Pfizer declined to disclose whether it plans to seek U.S. approval for a long-term or continuous prophylactic treatment regimen with the recombinant coagulation Factor IX (rFIX). ...