2025.12.20 (토)

  • 흐림동두천 6.6℃
  • 흐림강릉 9.5℃
  • 흐림서울 8.2℃
  • 구름많음대전 5.7℃
  • 박무대구 1.6℃
  • 박무울산 8.2℃
  • 흐림광주 8.6℃
  • 맑음부산 13.3℃
  • 흐림고창 13.5℃
  • 흐림제주 14.2℃
  • 흐림강화 8.6℃
  • 흐림보은 1.3℃
  • 흐림금산 1.9℃
  • 구름많음강진군 6.0℃
  • 맑음경주시 3.5℃
  • 맑음거제 7.2℃
기상청 제공

경제

TECFIDERA® (Dimethyl Fumarate) Approved in the European Union as a First-Line Oral Treatment for Multiple Sclerosis

[By NBC-1TV H. J Yook]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(www.biogenidec.com) (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.[1] 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.”



배너

관련기사


배너
배너
배너
배너
배너
배너
배너
배너
배너
배너
배너
배너