logo
Share SHARE
FONT-SIZE Plus   Neg

Biogen Idec: Positive Results From CONFIRM MS Trial Show Efficacy Of Oral BG-12

Biogen Idec (BIIB) said detailed positive data from CONFIRM, the second Phase 3 trial of oral BG-12, or dimethyl fumarate, in people with relapsing-remitting multiple sclerosis, or RRMS, will be presented in three platform presentations at the 64th Annual Meeting of the American Academy of Neurology in New Orleans.

In CONFIRM, BG-12 demonstrated efficacy across a variety of clinical and radiological outcome measures, as well as favorable safety and tolerability profiles. These data, along with results from BG-12's first Phase 3 study, DEFINE, were included in regulatory applications that were submitted to U.S. and EU regulatory agencies early this year.

Earlier this year, Biogen Idec announced that it had submitted a New Drug Application to the U.S. Food and Drug Administration for marketing approval of BG-12 in the United States and a Marketing Authorisation Application to the European Medicines Agency, or EMA, for review in the European Union. The EMA has validated Biogen Idec's Marketing Authorisation Application and is reviewing the BG-12 data package. Biogen Idec is awaiting formal acceptance of its NDA for review by the FDA.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Alteryx, Inc., a provider of self-service data analytics software, is the latest tech company to go public in March. Alteryx said it has priced its IPO of 9 million shares of its Class A common stock at $14 per share, at the top end of its range of $12 to $14 per share. Dunkin' Donuts is bidding adieu to one of its frozen coffee beverages this summer. However, loyal fans of the decades-old menu staple have not taken kindly to the news. The coffee chain said it will discontinue its popular Coffee Coolatta beverage this summer and instead, introduce the new Frozen Dunkin' Coffee, made with coffee extract, sugar and milk. Canadian pipeline operator Enbridge Inc. said it will cut about 1,000 jobs, or six percent of its workforce, following the completion of its acquisition of Houston-based Spectra Energy Corp. The job cuts will take place across the merged company.
comments powered by Disqus
Follow RTT