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Today Biogen Idec
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.”
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