CSL Behring announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for rIX-FP (Coagulation Factor IX [Recombinant], Albumin Fusion Protein), for patients with hemophilia B. rIX-FP is engineered to extend the half-life of recombinant factor IX through genetic fusion with recombinant albumin.
The BLA submission was based on results from the Phase 2/3 PROLONG-9FP study, an open-label, multicenter, safety, pharmacokinetic (PK) and efficacy study of rIX-FP in previously treated patients with severe hemophilia B (FIX ≤2%). The primary outcome measures for this study were to compare the change in frequency of spontaneous bleeding events between on-demand treatment and a weekly prophylaxis regimen in patients previously receiving only on-demand treatment; and the number of patients developing inhibitors against factor IX. The study evaluated multiple prophylaxis regimens, including 7-day and 14-day intervals. A sub-study evaluated the prevention and control of bleeding in patients with hemophilia B undergoing a surgical procedure.
In 2012, the FDA granted Orphan Drug designation to rIX-FP for the treatment and prophylaxis of bleeding episodes in patients with hemophilia B.
For more information call (800) 504-5434 or visit CSLBehring.com.