BOSTON (Reuters) – Biogen Idec Inc said on Wednesday its experimental treatment for patients with hemophilia A, a disorder that inhibits coagulation of the blood, controlled bleeding in a late-stage clinical trial.
Biogen, which makes the multiple sclerosis drugs Avonex and Tysabri, said it plans to submit an application to market the drug with the U.S. Food and Drug Administration in the first half of 2013. It will file with European regulators after it completes a study of the drug in children.
Last month, Biogen and its partner Swedish Orphan Biovitrum AB (Sobi), reported promising results of a trial of their drug to treat hemophilia B, a less common form of the disease.
Hemophilia is a new disease area for Biogen.
Hemophilia A is caused by a lack, or insufficient amount of, the blood coagulation factor VIII. Patients with hemophilia B lack or have reduced levels of coagulation factor IX.
Biogen’s drugs are designed to cut the number of infusions needed to control bleeding. Existing Factor VIII products must be taken as many as three to four times a week. Factor IX products must be taken intravenously two or three times a week.
In Biogen’s latest study, known as A-LONG, 98 percent of bleeding episodes were controlled with one or two injections of its long-lasting Factor VIII drug.
Individual and weekly preventative regimens resulted in median annualized bleeding rates in the low single digits, the company said.
The market for hemophilia A treatments is worth about $ 5 billion, according to Biogen, while the market for hemophilia B treatments is about $ 1 billion
(Reporting By Toni Clarke; Editing by Alden Bentley and Gerald E. McCormick)
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Biogen’s hemophilia-A drug meets late-stage trial goal
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