EU approval for Tecfidera for Multiple Sclerosis-Biogen IDEC

Tecfidera (dimethyl fumarate) from Biogen IDEC has been approved by the European Commission (EC) as a first-line oral treatment for people with relapsing-remitting Multiple Sclerosis (RRMS), the most common form of Multiple Sclerosis (MS). Biogen Idec will begin to introduce Tecfidrea in initial European Union (EU) countries in the coming weeks.

Tecfidera was first approved in the United States in March 2013 and became the country�s number one prescribed oral therapy for relapsing forms of MS after six months. Tecfidera is also approved in Canada and in Australia in 2013.

The EC approval is based on a robust clinical development program that included two global Phase III 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.