Orphan Drug Status Granted for rIX-FP for Congenital Factor IX Deficiency (Hemophilia B)
CSL Behring announced that the FDA has granted orphan drug designation for its recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP) for the treatment and prophylaxis of bleeding episodes in patients with congenital factor IX deficiency (hemophilia B). The designation includes routine prophylaxis treatment, control and prevention of bleeding episodes, and prevention and control of bleeding in perioperative settings.
CSL Behring has engineered rIX-FP to extend the half-life of Factor IX through genetic fusion with recombinant albumin. The cleavable linker connecting recombinant factor IX and recombinant albumin has been specifically designed to preserve the native function of the coagulation factor in the fusion protein, while benefiting from recombinant albumin's long physiological half-life.
For more information call (800) 504-5434 or visit www.cslbehring.com.