CSL Behring announced that the Food and Drug Administration (FDA) has approved Idelvion (coagulation factor IX [recombinant], albumin fusion protein) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes, on-demand control and prevention of bleeding episodes, and the perioperative management of bleeding (around the time of surgery).
Idelvion is comprised of genetically fused recombinant coagulation Factor IX and recombinant albumin. Fusion with recombinant albumin extends the half-life of Factor IX. It is the first factor IX therapy to provide protection with up to 14-day dosing regimens in select patients aged ≥12 years. The 14-day dosing interval was able to maintain high factor activity of >5% at 75 IU/kg.
The FDA approval was based on data from the PROLONG-9FP clinical program that included Phase 1 through 3 open-label, multicenter studies evaluating the safety and efficacy of Idelvion in patients aged 1-61 years with hemophilia B (factor IX levels ≤2%). Median annualized spontaneous bleeding rates (AsBR) of zero and factor IX activity levels >5% were seen in patients administered Idelvion prophylactically; this results was achieved with both 7- and 14-day dosing. With on-demand therapy, 94% of bleeds were controlled with one infusion and 99% were controlled with 1 or 2 infusions.
Idelvion will be available as a lyophilized powder in single-use vials containing nominally 250 IU, 1000 IU, or 2000 IU. It is anticipated to launch later this month.
For more information call (866) 915-6958 or visit Idelvion.com.