FDA Approves Biogen’s Hemophilia B Drug, Alprolix

FDA Approves Biogen’s Hemophilia B Drug, Alprolix

U.S. Food and Drug Administration (FDA) has given green signal to long-lasting hemophilia B drug to treat multiple sclerosis by Biogen Idec Inc. The company said that the drug has Factor IX molecule which makes the product last longer in circulation.

The drug, Alprolix, developed by collaboration of Biogen and Swedish Orphan Biovitrum AB (SOBI) has been approved to treat the blood disorder. Tony Kingsley, executive vice president of Biogen’s global commercial operations, said the current treatment performs several infusions a week, but the new drug reduces the need for infusions.

The company said that the novel drug may be infused once a week depending on patient and can give tough competition to Pfizer Inc.’s BeneFix, which has generated revenue of $832 million in 2013. The company found controlled bleeding with one shot of the drug in about 90% of the patients.

Kingsley said that about 4,000 people in U.S. suffer from hemophilia B, an inherited disorder that impairs blood coagulation and leads to bleeding. The disease is at increased risk in males and is far less common compared to hemophilia A.

The approval of the drug by the FDA has allowed the Biogen to sell the drug for seven years without generic competition. Hemophilia B, also called as Christmas disease, affects those patients with low levels of blood protein i.e. Factor IX.

The Company is planning to launch Eloctate, its hemophilia A drug into the market by the idle of the year.


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