* Steady-state levels measured FIX at trough levels before each infusion every four weeks until week 92 at 7-day prophylaxis and week 104 at 14-day prophylaxis. †Mean calculated from the entire length of study. For the duration of the phase III study, mean FIX activity was 20.0% with 7-day dosing, while mean FIX activity was 12.4% with 14-day dosing.2
‡After administration of a single infusion of IDELVION. §Data from the phase I trial, a first-in-human prospective, multicenter, open-label, dose-escalation study to evaluate the safety and PK of 25, 50, and 75 IU/kg rIX-FP in subjects with hemophilia B. Twenty-five subjects were enrolled in order to ensure at least 13 evaluable subjects in the 50 IU/kg dosing group, and at least 4 evaluable subjects in both the 25 and 75 IU/kg rIX-FP dosing groups. All subjects received rIX-FP in a non-bleeding state and after a washout period of at least 4 days from their last dose of the previous FIX product.3
*Steady-state levels measured FIX at trough levels before each infusion at weeks 4, 12, 24, and 36 at 7-day prophylaxis.
†Mean calculated from the entire length of study.