Biogen Idec Inc said on Friday it had won Canadian approval for its long-lasting hemophilia B drug Alprolix.
Hemophilia B, a rare inherited disorder in which the ability of a person's blood to clot is impaired, affects some 4,000 people in the United States and roughly 25,000 worldwide.
Biogen is developing the drug in partnership with Swedish Orphan Biovitrum AB. It is expected to be approved in the United States later this year.
Traditional hemophilia treatments must be infused two to three times a week, while Biogen's drug needs to be administered only once a week or once every 10 to 14 days to protect against bleeding episodes.
Alprolix is a bioengineered version of the blood coagulation factor IX, a protein needed for normal blood clotting. A single injection of the drug controlled bleeding in more than 90 percent of cases in a late-stage clinical trial.
Biogen is also developing a drug, Elocate, to treat hemophilia A, a more common form of the disease that affects an estimated 20,000 people in the United States. Patients with hemophilia A lack or have reduced levels of coagulation factor VIII.
Current treatments for hemophilia B generate about $1 billion a year, according to Biogen, while the market for hemophilia A therapies is about $6 billion.
If approved in the United States, Alprolix is expected to generate sales of $286 million by 2019, according to Thomson Reuters data. Elocate is expected to generate sales of $1.1 billion.
Biogen shares closed at $347.04 on the Nasdaq on Thursday.
(Reporting by Toni Clarke in Washington, Additional reporting by Esha Dey in Bangalore; Editing by Simon Jennings)