- In clinical trials, IDELVION maintained factor IX activity levels above 5 percent over 14 days, resulting in a median annualized spontaneous bleeding rate (AsBR) of 0.00
- IDELVION, CSL Behring’s long-acting recombinant albumin fusion protein, delivers on the company’s promise to develop and provide innovative specialty biotherapies that help people with serious medical conditions live full lives
KING OF PRUSSIA, Pa. – March 4, 2016 – CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein], its novel, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for the treatment of hemophilia B. IDELVION is the first and only factor IX therapy that delivers high-level protection with up to 14-day dosing in appropriate patients. This dosing interval has been achieved while maintaining high levels of factor activity, above 5 percent over 14 days at 75 IU/kg. This reduces the monthly number of units needed for prophylaxis therapy.
IDELVION is indicated 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). Appropriate patients 12 and older can go up to 14 days between infusions. IDELVION is expected to be available later this month.
Hemophilia B is a congenital bleeding disorder characterized by deficient or defective factor IX; nearly all affected patients are male. People with hemophilia B may experience prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. According to U.S. Centers for Disease Control and Prevention, the condition affects approximately one in 25,000 male births.