Positive new data on Pfizer's BeneFIX for hemophilia B prophylaxis

US pharma giant Pfizer (NYSE: PFE) has announced the publication of positive Phase III study results of a once-weekly regimen of BeneFIX (coagulation Factor IX [recombinant]) 100 IU/kg prophylaxis versus on-demand treatment in people with moderately severe or severe hemophilia B. The findings were published in Haemophilia, the official journal of the World Federation of Hemophilia.

“In this study, a once-weekly prophylactic regimen with BeneFIX provided a significant reduction in bleeding, which is an important goal in managing hemophilia,” said Pablo Rendo, global clinical lead, senior director, Physician Clinicians at Pfizer.

The study showed that the median ABR (annualized bleeding rate) values were 2.0 (range, 0.0-13.8) for the prophylaxis period and 33.6 (range, 6.1-69.0) for the on-demand period. The mean ABR values were 3.6 ± 4.6 for the prophylaxis period and 32.9 ±17.4 for the on-demand period, which were statistically significantly different (p <0.0001).During the 52 weeks of the prophylaxis period, 36% of patients experienced no bleeding events of any kind, and 48 percent of patients experienced no spontaneous bleeding events.