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Canadian health officials have okayed a Biogen Idec Inc. drug that controls and prevents bleeding in patients with hemophilia B, marking the first approval of a new hemophilia treatment in nearly two decades and the entry of the Cambridge biotech into a market beyond multiple sclerosis medicines.
The approval by Health Canada, disclosed Friday by Biogen Idec, sets the stage for Food and Drug Administration decision on whether to allow the drug, called Alprolix, into the larger US market. An estimated 4,000 people, mostly men, suffer from hemophilia B in the United States, compared with 700 in Canada, and 28,000 worldwide.
Biogen Idec has also filed for approval of Alprolix with regulatory bodies in Australia and Japan.