Biogen Idec, Inc. (Massachusetts) (BIIB) Release: New Data From Phase 3 Studies Provide Additional Evidence Supporting Treatment Effect for Oral BG-12 (Dimethyl Fumarate) in Multiple Sclerosis
10/12/2012 9:51:54 AM
WESTON, Mass.--(BUSINESS WIRE)--Today Biogen Idec (NASDAQ: BIIB) announced new data from studies evaluating oral BG-12 (dimethyl fumarate), which provide further evidence supporting its strong clinical and radiological effects in people with relapsing-remitting multiple sclerosis (RRMS) and reinforce its favorable safety profile seen to date. These data were presented at the 28th Congress of the European Committee for the Treatment and Research of Multiple Sclerosis (ECTRIMS) in Lyon, France. In a pre-specified analysis of integrated, or pooled, data from the Phase 3 DEFINE and CONFIRM studies, dimethyl fumarate showed statistically significant and clinically relevant effects in reducing multiple sclerosis (MS) relapses and progression of disability, as well as reductions in magnetic resonance imaging (MRI) measures of disease activity. In addition, interim safety data from a Phase 3 extension study indicate that continued exposure to dimethyl fumarate did not result in any new or worsening safety signals, and that its safety and tolerability profiles were consistent with previous studies.