Biogen Gets FDA Approval for Milestone Hemophilia Therapy

April 8, 2014

The U.S. FDA has approved Biogen Idec's Alprolix, the first recombinant, DNA derived hemophilia B therapy with prolonged circulation in the body.

Hemophilia B is a rare, chronic, inherited disorder in which the ability of a person’s blood to clot is impaired, which can lead to recurrent and extended bleeding episodes. According to Biogen, the Alprolix approval is the first significant advance in hemophilia B treatment in more than 17 years. The therapy is clinically proven to reduce bleeding episodes with a favorable safety and tolerability profile. It is the first hemophilia therapy to demonstrate prolonged circulation in the body, which has been shown in adults and adolescents with hemophilia to extend the time between prophylactic infusions.

Biogen plans to make Alprolix commercially available to people with hemophilia B in the U.S. in early May.

Read the Biogen press release