(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).
(NASDAQ: BIIB) 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.
TECFIDERA was also approved in Canada and in Australia in 2013.
“TECFIDERA exemplifies our commitment to deliver innovative therapies that help people living with serious diseases,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “We already have seen TECFIDERA’s significant impact on transforming the standard of care for MS where it is available and are excited to quickly bring its benefits to patients in the EU as well.”
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.
“As a physician, I am all too familiar with the challenges my patients experience while managing their MS. TECFIDERA may lower this burden for many because it is an oral therapy that has been proven to lessen disease activity effectively while maintaining a favorable safety profile,” said Ralf Gold, M.D., professor and chair of the Department of Neurology, St. Josef-Hospital/Ruhr-University Bochum and lead investigator of DEFINE. “Moreover, the positive experience we have had with TECFIDERA throughout its extensive clinical program gives me confidence about the benefits this oral therapy may offer my patients in the EU.”