Idelvion is the albumin fusion protein that links recombinant coagulation factor IX with recombinant albumin to treat hemophilia B.
CSL Behring claims that the drug is the first and only factor IX therapy that offers high-level protection with up to 14-day dosing in appropriate patients.
In clinical trials, Idelvion maintained factor IX activity levels above 5% over 14 days, resulting in a median annualized spontaneous bleeding rate of 0.00.
Idelvion is indicated in children and adults with hemophilia B for on-demand control and prevention of bleeding episodes; perioperative management of bleeding; routine prophylaxis to avoid or reduce frequency of bleeding episodes.
CSL chief scientific officer and R&D director Andrew Cuthbertson said: "Idelvion has the potential to significantly impact the treatment of hemophilia B as it maintains factor IX activity levels above 5 percent over a prolonged period of time. This provides excellent bleeding control."
Idelvion is the first product from the company’s recombinant factor development program to secure FDA approval.
Last month, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use recommended granting marketing authorization for Idelvion.
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 suffer prolonged or spontaneous bleeding, particularly into the muscles, joints, or internal organs.