New MS Drug Approved By FDA Despite Teva's Opposition

Law360, New York (March 28, 2013, 4:36 PM EDT) -- Biogen Idec Inc. won U.S. Food and Drug Administration approval Wednesday for multiple sclerosis treatment Tecfidera, thwarting Teva Pharmaceutical Industries Ltd.’s attempt to delay the product by raising safety concerns and adding a likely blockbuster to the company’s portfolio.

In announcing the clearance, Biogen touted extensive clinical trials that found Tecfidera cut by about 50 percent the number of patients who relapsed, and pointed to an ongoing study in which some patients receiving the drug have been followed for more than four years. Those comments amounted...
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