• Eva Havrdova, Michael Hutchinson, Nuwan C Kurukulasuriya, Kartik Raghupathi, Marianne T Sweetser, Katherine T Dawson, and Ralf Gold.
• Charles University in Prague, First Faculty of Medicine, Department of Neurology , Prague , Czech Republic +420224966422 ; +420224917907 ; ehavr@lf1.cuni.cz.
• Expert Opin Pharmacother. 2013 Oct 1;14(15):2145-56.

IntroductionMultiple sclerosis (MS) is an autoimmune neurodegenerative disease of the central nervous system involving inflammation, chronic demyelination and axonal loss. MS affects more than 2 million people worldwide.Areas CoveredThis article aims to summarize the findings from two pivotal 2-year, randomized, double-blind, placebo-controlled, Phase III studies of BG-12 (dimethyl fumarate) for relapsing-remitting MS (RRMS): DEFINE (Determination of the Efficacy and Safety of Oral Fumarate in RRMS) and CONFIRM (Comparator and an Oral Fumarate in RRMS). Results from both studies demonstrated that BG-12 provides clinical and radiological efficacy over 2 years across a range of outcomes. These results were apparent as early as 12 weeks and sustained over the course of both studies. BG-12 was found to have an acceptable safety profile, with a similar overall incidence of adverse events across all treatment groups.Expert OpinionThe combination of robust efficacy, ease of administration and established safety profile is unique to a new therapy in MS. Findings from the pivotal Phase III studies support BG-12 as a potential initial oral treatment for patients with RRMS or as an alternative to other currently available therapies.

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