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Biogen Says Data Shows Potential for BG-12 as an MS Treatment


Today Biogen Idec (NASDAQ: BIIB) announced that detailed results from its two pivotal clinical trials evaluating oral BG-12 (dimethyl fumarate) for the treatment of multiple sclerosis (MS) were published in the Sept. 20, 2012 issue of The New England Journal of Medicine (NEJM).

Data from the Phase 3 DEFINE and CONFIRM studies show that dimethyl fumarate (240 mg), administered twice daily (BID) or three times daily (TID), demonstrated significant and clinically meaningful reductions in MS relapses and brain lesions in patients with relapsing-remitting multiple sclerosis (RRMS) compared to placebo, as well as showed benefit in slowing the progression of the disease. Dimethyl fumarate is currently under review by regulatory authorities in the United States, European Union, Australia, Canada and Switzerland.

“The publication of both dimethyl fumarate pivotal studies in NEJM is another achievement for this important investigational therapy,” said Katherine Dawson, M.D., senior medical director, Biogen Idec Neurology Research and Development and Biogen Idec lead author on both dimethyl fumarate manuscripts in NEJM. “The data from its clinical development program consistently indicate that dimethyl fumarate may provide tangible benefits and address existing treatment needs of people living with MS. We are working closely with regulatory authorities across the globe with the aim of making the review of dimethyl fumarate as quick as possible.”

Posted-In: News FDA


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