Biogen MS Drug Meets Primary Endpoint

Biogen Idec Inc's experimental multiple sclerosis drug met the main goal in the first of two important late-stage studies.

The U.S. biotechnology company Biogen Idec reported positive results from DEFINE, a Phase III trial evaluating the investigational oral compound BG-12 (dimethyl fumarate) as a monotherapy in people with relapsing-remitting multiple sclerosis (RRMS).

DEFINE, the first of two Phase III trials, was a global, randomized, double-blind, placebo-controlled, dose-comparison study to determine the efficacy and safety of BG-12 in people with RRMS.

Results showed that 240 mg of BG-12, administered either twice or three times a day, met the primary study endpoint, demonstrating a statistically significant reduction in patients with RRMS who relapsed at two years compared with placebo. Both doses of BG-12 also met all of the secondary study endpoints, providing a statistically signific