logo
Share SHARE
FONT-SIZE Plus   Neg

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

Biogen Idec (BIIB) 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

Quick Facts

Editors Pick
Even after two years of thoroughly searching across the Indian Ocean, using modern technologies and devices, there is no clue about the Malaysian airline that vanished on March 8, 2014. Internet access is growing worldwide, but there is still a long way to go before the entire world is completely wired, a study from the Pew Research Center has found. The study also noted that men have greater access to the Internet than women in many nations. Backtracking on its early announcements on digital privacy, WhatsApp is planning to share member information, phone numbers and analytical data with Facebook, to make revenue from the platform.
comments powered by Disqus
Follow RTT