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
The Justice Department has initiated a probe to find out if airlines are colluding to limit seating capacity in order to benefit from higher airfares. Saudi Prince Alwaleed Bin Talal Bin Abdulaziz Alsaud has pledged to give away his entire wealth amounting to $32 billion for charity. He said the fund will be utilized for cultural understanding, develop communities, empower women, enable youth, provide vital disaster relief and create a more tolerant and accepting world. Toyota accepted the resignation of its Chief Communications Officer Julie Hamp, following her arrest in Japan for allegedly mailing banned painkillers to her address in Japan from U.S.
comments powered by Disqus
RELATED NEWS
Trade BIIB now with 
Follow RTT