Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Biogen Seeks FDA Nod For Oral BG-12 To Treat Multiple Sclerosis - Quick Facts

RELATED NEWS
Trade BIIB now with 

Biogen Idec (BIIB: Quote) said it has submitted a New Drug Application, or NDA, to the U.S. Food and Drug Administration, or FDA, for marketing approval of BG-12 (dimethyl fumarate), the company's oral therapeutic candidate for the treatment of multiple sclerosis, or MS.

The company stated that the regulatory submission was based on BG-12's comprehensive development program, in which BG-12 demonstrated significant reductions in MS disease activity coupled with favorable safety and tolerability in the Phase 3 DEFINE and CONFIRM studies.

Biogen noted that it intends to submit a Marketing Authorisation Application for BG-12 to the European Medicines Agency within the coming days.

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

Editors Pick
After failing to sustain an initial upward move, stocks fluctuated over the course of the trading session on Wednesday before ending the day mixed. The choppy trading came as traders digested upbeat GDP data as well as the Federal Reserve's monetary policy announcement. President Barack Obama took Congress to task in remarks on the economy on Wednesday, accusing Republicans of wasting valuable time by voting on a resolution regarding whether or not to sue him over his use of executive actions. In a surprise move, the Senate voted Tuesday to make changes to an important House highway funding bill, raising questions about whether the legislation will receive final approval before lawmakers leave town for the August recess.
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.