Two months after US regulators approved the first new hemophilia treatment in 17 years, its maker, Biogen Idec Inc., got the okay Friday to market a similarly long-acting drug that controls and prevents bleeding in adults and children with the most common form of the disease.
Food and Drug Administration approval of Eloctate opens a new market for Cambridge-based Biogen Idec among an estimated 16,000 people in the United States with hemophilia A. The inherited disorder prevents normal blood clotting in patients, leading to recurrent and extended bleeding that can cause pain and joint damage.
“The approval of this product provides an additional therapeutic option for use in the care of patients with hemophilia A,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research.
About four times as many people suffer from hemophilia A than from hemophilia B. Biogen Idec won FDA approval on March 28 to sell another drug, called Alprolix, based on the same mechanism of action as Eloctate, to treat hemophilia B.
“The innovation here is very similar to the innovation we brought forward with Alprolix,” said Doug Williams, executive vice president of research and development at Biogen Idec.
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