Biogen announced that TECFIDERA has been approved by the European Commission as a first-line oral treatment for people with relapsing-remitting multiple sclerosis. Biogen will begin to introduce TECFIDERA in initial European Union countries in the coming weeks. The EC approval is based on a clinical development program that included two global Phase 3 clinical trials, DEFINE and CONFIRM, as well as an ongoing extension study, ENDORSE, in which some patients have been followed for up to six and a half years. TECFIDERA has been clinically shown to "significantly" reduce important measures of disease activity, including relapses and the development of brain lesions, as well as to slow disability progression, while demonstrating a favorable safety and tolerability profile.