FDA Green Lights First Coagulation Factor-Albumin Fusion Protein

The FDA has approved coagulation factor IX (recombinant), albumin fusion protein (Idelvion) for the treatment of hemophilia B in patients aged 12 years and older.

The FDA has approved coagulation factor IX (recombinant), albumin fusion protein (Idelvion) for the treatment of hemophilia B in patients aged 12 years and older.

Idelvion is indicated for:

  • Routine prophylaxis
  • “On-demand” management and prevention of bleeding episodes
  • Perioperative management of bleeding

Idelvion was developed to extend recombinant factor IX’s half-life via fusion with recombinant albumin. It is the first coagulation factor-albumin fusion protein product to receive FDA approval.

According to a press release from drug manufacturer CSL Behring, Idelvion is designed to deliver high-level protection for up to 14 days in certain patients. In fact, a dose of 75 IU/kg was shown to maintain high levels of factor activity above 5% over 14 days.

As a result, patients on Idelvion require less frequent infusions when using the drug as prophylaxis. Furthermore, it is the second factor IX fusion protein product approved in the United States.

The approval was based on 2 multicenter studies that evaluated the safety and efficacy of Idelvion in a total of 90 patients with hemophilia B between the ages of 1 and 61 years.

The FDA reported that the studies results showed that Idelvion was effective in controlling bleeding episodes as well as managing bleeding after surgery. In addition, Idelvion used as prophylaxis resulted in a significant reduction in the rate of spontaneous bleeding episodes per year, even with less frequent infusions.