Biogen Idec Wins First Approval For Alprolix In Canada

Biogen Idec announced that it has won its first approval for its hemophilia drug Alprolix in Canada. Alprolix is currently under review for regulatory approval in other countries including Japan, Australia, and the U.S.

The drug is the first approved long-acting hemophilia B therapy and is indicated to prevent or decrease the frequency of bleeding episodes with prophylactic infusions beginning at once weekly or once every 10 to 14 days. Alprolix was approved by Health Canada for the control and prevention of bleeding episodes and routine prophylaxis in adults and adolescents aged 12 years and older with hemophilia B.

George Scangos, chief executive officer of Biogen Idec, said “Health Canada’s approval of Alprolix marks the first significant treatment advance in hemophilia B in 17 years, and reinforces our commitment to developing innovative therapies that help address the critical needs of the hemophilia community. We believe that the safety, efficacy and prophylactic dosing schedule demonstrated with Alprolix will provide people with hemophilia B a meaningful new way to manage their condition.”

Hemophilia B is an inherited, chronic, and rare disorder in which the body’s ability to make blood clots is impaired, leading to recurrent and extended bleeding episodes in patients. A substantial reduction of or no factor IX activity is implicated in the disease, which could cause irreversible joint damage and hemorrhage. Hemophilia B affects about one in 25,000 male births and about 700 people in Canada.

Manuel Carcao, pediatric hematologist and co-director of the Comprehensive Care Hemophilia Program at the Hospital for Sick Children in Toronto, said “Health Canada’s approval of Alprolix provides people with hemophilia B an important new option in maintaining a prophylactic regimen. Alprolix, the first approved long-acting factor concentrate, has been shown to help individuals with hemophilia B achieve effective bleed prevention with prophylactic dosing once a week or once every 10 to 14 days.”

The company said it is working with Canadian Blood Services and other provincial as well as national authorities in order to make Alprolix commercially available to Canadian patients with hemophilia B.