February 03, 2014
TECFIDERA (dimethyl fumarate) 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 TECFIDERA 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.1 TECFIDERA was 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 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.
TECFIDERA is the fourth therapy Biogen Idec offers to people living with MS.
Find the full press release here.
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