FDA Approves First Coagulation Factor–Albumin Fusion Protein for Hemophilia B

The U.S. Food and Drug Administration (FDA) approved coagulation factor IX (recombinant), albumin fusion protein, also known as albutrepenonacog alfa, for use in children and adults with hemophilia B. This is the first coagulation factor–albumin fusion protein product and the second factor IX fusion protein product to be approved in the United States.

Albutrepenonacog alfa combines albumin and factor IX and, because it is modified to last longer in the blood, it reduces injection frequency. It is indicated for on-demand control and prevention of bleeding episodes, the management of peri-operative bleeding, and as routine prophylaxis to reduce the frequency of bleeding episodes.

The product’s approval is based on results from two multi-center clinical trials that evaluated the safety and efficacy of albutrepenonacog alfa in 90 adult and pediatric patients with hemophilia B (age range = 1-61 years). Albutrepenonacog alfa effectively controlled bleeding episodes and managed peri-operative bleeding. It also reduced the rate of spontaneous bleeding events per year, despite fewer infusions being required.

The most common adverse event was headache, and no other safety concerns were noted.

Source: U.S. FDA press release, March 4, 2016.