FDA Accepts BLA for CSL’s rIX-FP for Hemophilia B Patients
- By BSTQ Staff
CSL Behring’s Biologics License Application for the marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin, rIX-FP, has been accepted for review by the U.S. Food and Drug Administration. When approved, rIX-FP will provide hemophilia B patients with a long-acting treatment option with dosing intervals up to 14 days. CSL engineered rIX-FP to extend the half-life of recombinant factor IX through genetic fusion with recombinant albumin due to its long physiological half-life, as well as its good tolerability profile, low potential for immunogenic reactions and a well-known mechanism of clearance.
CSL’s BLA is based on the results from the Phase II/III study in the PROLONG- 9FP program, which compared the change in frequency of spontaneous bleeding events between on-demand treatment and a weekly prophylaxis regimen in patients ages 12 to 61 years who develop inhibitors against factor IX. The study evaluated multiple prophylaxis regimens, including seven-day and 14-day intervals. A sub-study evaluated the prevention and control of bleeding in patients with hemophilia B undergoing a surgical procedure.
