Positive Phase 3 Results for Once Weekly Prophylaxis for Hemophilia B
The study was an open-label, non-randomized two-period study consisting of six months of on-demand therapy only, followed by 12 months of routine prophylaxis with BeneFIX once-weekly. The primary endpoint was reached and patients taking once-weekly BeneFIX also showed a statistically significant reduction in the annualized bleeding rate (ABR) (P<0.0001) relative to on-demand treatment.
The median ABR value 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, representing an 89% reduction (P<0.0001). Study results also demonstrated that prophylaxis treatment significantly reduced both spontaneous and traumatic ABR compared to on-demand treatment with BeneFIX. The median spontaneous ABR value was 1.0 for the prophylaxis regimen vs. 22.4 for the on-demand regimen and the median traumatic ABR value was 1.0 for the prophylaxis period vs. 4.1 for the on-demand treatment.
BeneFIX is a recombinant coagulation factor IX product, already approved for the control, prevention, and perioperative management of bleeding episodes in adult and pediatric patient with hemophilia B. It has been studied in clinical trials in both previously treated and untreated patients, and established in both on-demand and preventive care, additionally shown to help control bleeds in major and minor surgeries.
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