Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Biogen Idec has announced positive data from the Phase 3 DEFINE clinical trial, which tested the efficacy of oral BG-12 (dimethyl fumarate) to treat relapsing-remitting multiple sclerosis (RRMS).
Subscribe to our email newsletter
DEFINE (Determination of the Efficacy and safety of oral Fumarate IN rElapsing-remitting MS) a global, randomized, double-blind, placebo-controlled, dose-comparison trial enrolled 1,237 patients between 18 and 55 years of age.
The study demonstrated that 240 mg of BG-12, administered either twice a day (BID) or three times a day (TID), reduced the proportion of patients who relapsed by 49% and 50%, respectively, at two years as compared with placebo.
BG-12 also showed a reduction in the annualized relapse rate (ARR) and the risk of disability progression as measured by the Expanded Disability Status Scale (EDSS) at two years compared to patients on placebo.