US biotech firm Biogen Idec (Nasdaq: BIIB) says that data from the Phase III DEFINE and CONFIRM studies show that BG-12 (dimethyl fumarate) 240mg, administered twice daily (BID) or three times daily (TID), demonstrated significant and clinically meaningful reductions in multiple sclerosis relapses and brain lesions in patients with relapsing-remitting multiple sclerosis (RRMS) compared to placebo, as well as showing benefit in slowing the progression of the disease.
The results of the two pivotal clinical trials were published in the New England Journal of Medicine (September 20 issue). Dimethyl fumarate is currently under review by regulatory authorities in the USA, European Union, Australia, Canada and Switzerland.
Peak sales potential of $3 billion projected
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