Biogen Idec's BG-12 enters large-scale Ph III program in RR-MS

US drugmaker Biogen Idec has initiated a Phase III clinical program on BG-12, its oral fumarate in development for relapsing-remitting multiple sclerosis. The DEFINE (determination of the efficacy and safety of oral fumarate in relapsing-remitting MS) and CONFIRM (comparator and an oral fumarate in relapsing-remitting MS) studies will include more than 2,000 total patients in North America, Europe and rest of world. These two-year, randomized, multicenter, double-blind, placebo-controlled, dose-comparison evaluations have been globally initiated, and Biogen Idec plans to start them in the USA later this year.