logo
Share SHARE
FONT-SIZE Plus   Neg

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

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
H&R Block, Inc., the largest U.S. tax preparer, said Wednesday after the markets closed that its third quarter loss narrowed sharply from last year, as revenue surged due to an earlier opening of the Internal Revenue Service's e-file system this tax season. The company's quarterly loss per share also smaller than analysts estimated, but its quarterly revenue fell short of analysts' forecast. Microsoft co-founder Paul Allen's maritime plunge took an exciting yet somber turn, after he found the wreck of a once-feared World War II Japanese battleship that met its doom by enemy torpedoes decades ago near the Philippines. A new study reveals that more large companies in the U.S. are run by men with the names John, Robert, William or James than the total number of women CEOs. For each women CEO of S&P 1500 companies there are four men CEOs named John, Robert, William or James, according to a study conducted by the New...
comments powered by Disqus
Follow RTT