FDA Approves Alprolix for Hemophilia B

Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein], indicated for the prevention or reduction of bleeding episodes for patients with hemophilia B, was FDA-approved on March 28, 2014. It is the first treatment for hemophilia B that has prolonged circulation in the body, requiring less frequent injections. Alprolix can be administered for routine prophylaxis once every week or once every 10 days, depending on the dose.

“The hemophilia community is excited about new therapy options for the prophylactic management of hemophilia B,” said Val Bias, chief executive officer of the National Hemophilia Foundation. “This approval is a significant step forward because it provides an important new option and expanded choice for the hemophilia B community.”

A clinical trial that enrolled 123 Hemophilia B patients, ages 12-71, evaluated the safety and efficacy of Alprolix for prophylaxis and on-demand treatment. Alprolix was shown to be effective in treating and preventing bleeding episodes and the study did not reveal any safety issues.

Alprolix, manufactured by Biogen Idec, Inc., Cambridge, Mass, was designated as an orphan drug because hemophilia B is a rare disease, affecting about 4,000 people in the United States. It is priced at $2.85 per unit, which is more than twice the price of Benefix, an older treatment for hemophilia B that is priced at $1.19 per unit. Alprolix is dosed less frequently than Benefix, however, and prices vary widely based on the patient’s weight and how severe their disease is.