Quick Facts
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

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

RELATED NEWS
Trade BIIB now with 
4/24/2012 7:58 AM ET

Biogen Idec (BIIB: Quote) 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.

Click here to receive FREE breaking news email alerts for Biogen Idec and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Intel Corp. said Tuesday after the markets closed that its first quarter profit fell 5% from last year, hurt mainly by higher income tax expenses even as revenue grew slightly. The company's quarterly earnings per share came in above analysts' expectations, but its quarterly revenue fell shy of analysts' forecast. With traders digesting a mixed batch of catalysts, stocks saw considerable volatility over the course of the trading day on Tuesday before closing mostly higher. The gains on the day extended the recovery off the two-month lows set last Friday. The major averages showed a notable rebound in afternoon trading to end the day in positive territory. U.S. President Barack Obama and his Russian counterpart Vladimir Putin spoke regarding the ongoing crisis in Ukraine for the first time in over two weeks on Monday, although the two leaders remain far apart on the cause of escalating tensions.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.