Canadian authorities have approved Biogen Idecs Alprolix, which the drug maker says is the first new hemophilia treatment in 17 years. Alprolix, manufactured in Morrisville, is expected to win U.S. approval within three months, the company said.
Canada is the first country to approve Alprolix, an intravenous treatment also awaiting approval in Australia and Japan. The medication is designed to reduce bleeding from hemophilia B, a rare form of the blood-clotting disorder that has been diagnosed in about 28,000 people worldwide.
Cambridge, Mass.-based Biogen employs more than 6,000 people worldwide, including 1,200 in the Triangle. Biogens Morrisville facility currently makes two injection treatments for multiple sclerosis and will also manufacture Alprolix as well as a hemophilia A treatment thats expected to win U.S. approval this year.
Biogens shares closed Friday at $318.53, down $28.51. The stock is up 14 percent this year.
Hemophilia B is a rare inherited blood disorder that can lead to recurring and prolonged bleeding. People afflicted with it have low amounts of clotting factor IX, whereas the more common form, Hemophilia A, is characterized by low levels of clotting factor VIII.
Alprolix was tested on 123 men and boys aged 12 and older in the largest study of hemophilia B ever completed. Alprolix is injected between once and twice a week and is designed to control or prevent bleeding episodes.
The company said that 90 percent of all bleeding episodes in type B patients were controlled by a single Alprolix infusion.