Biogen Idec Inc's revolutionary hemophilia B drug has been approved for use in Canada, the company announced on Friday.
The move comes as precedent for further approvals, and it's anticipated that the United States will similarly give the drug the green light later this year. The drug, Alprolix, is administered relatively infrequently, with the average dosage pattern at most once per week - or even once every 10 to 14 days. To date, existing hemophilia B treatments require administration around 2 to 3 times per week, inconveniencing sufferers more than a weekly or fortnightly treatment would.
The drug mimics the blood coagulation factor IX, which sufferers typically lack. Factor IX enables normal clotting, with Alprolix bioengineered to control bleeding episodes. In 90 percent cases in late-stage trials, Alprolix was able to stem bleeding episodes with just one injection. The drug would likely be welcome for hemophilia B sufferers, with the rare, hereditary condition affecting around 25,000 people worldwide and 4,000 in America. "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," said Biogen Idec CEO George A. Scangos, Ph.D. "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."
Another drug, called Elocate, is in Biogen Idec's developmental pipeline as well, this time targeting sufferers of the more common hemophilia A, which affects around 20,000 in the United States alone. The treatments are also expected to boost revenue for Biogen Idec and partner company Swedish Orphan Biovitrum AB (Sobi), with Alprolix estimated to generate $286 million per year by 2019, and Elocate a further $1.1 billion.
"This first approval of this long-acting therapy for people with hemophilia B is an important milestone in our joint collaboration with Biogen Idec and marks the first significant advance in the treatment for this group in almost 20 years," said Sobi president and CEO Geoffrey McDonough. "We are proud to be part of this therapeutic advancement and look forward to bringing this treatment to people with hemophila."