CSL Behring announced that IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein], its novel, long-acting recombinant albumin fusion protein for treating hemophilia B, is now available nationwide. IDELVION is the first and only factor IX therapy that delivers high-level protection with up to 14-day dosing in appropriate patients. This extended dosing interval was achieved while maintaining high levels of factor activity, above 5 percent over 14 days at the highest dose, thereby reducing the number of units needed for monthly prophylaxis therapy.
IDELVION was approved by the FDA on March 4, 2016, for use in children and adults with hemophilia B 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). FDA approval ofIDELVION is based on results from the PROLONG-9FP clinical development program. Data from the global Phase III pivotal study were recently published in the American Society of Hematology’s publication Blood.
“IDELVION provides excellent bleeding control by maintaining factor IX activity levels above 5 percent over a prolonged period of time, resulting in a median annualized spontaneous bleeding rate of zero,” said Jerry Powell, M.D., Medical Director, North America Commercial Operations, CSL Behring. “We are proud to offer this long-acting therapy as a part of our broad portfolio of bleeding disorder products and are particularly excited about the positive impact IDELVION can have on the lives of patients with hemophilia B.”
IDELVION is available in four vial sizes: 250 IU, 500 IU, 1000 IU, and 2000 IU with low diluent volumes of 2.5 mL (250, 500, 1000 IU) or 5 mL (2000 IU). The product may be stored in the refrigerator or at room temperature (2-25°C; 36-77°F).
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