CSL Behring announced that the Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) 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 study was designed 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.
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.