Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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

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
Specialty drugmaker Horizon Pharma plc (HZNP) on Friday managed to redomicile itself as an entity incorporated in Ireland following the completion of its $660 million acquisition of Vidara Therapeutics International plc. The deal will help it avoid paying the high rate of U.S. corporate taxes. The... Stocks showed a lack of direction over the course of the trading day on Friday after failing to sustain an initial upward move. Despite the choppy trading, the Dow once again managed to end the session at a new record closing high. The major averages turned in a mixed performance on the day. President Barack Obama delivered a statement Thursday evening thanking members of Congress for voting to approve legislation granting the U.S. military the authority to train and arm moderate Syrian rebels fighting against the terrorist group known as the Islamic State.
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.