logo
Plus   Neg
Share
Email

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 RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Following the mixed performance seen last week, stocks are likely to move to the downside in early trading on Monday. The major index futures are currently pointing to a notably lower open for the markets, with the Dow futures down by 212 points. *European, Asian shares fall on Monday amid escalating U.S.-China trade tensions *Oil extends losses ahead of OPEC meeting later this week *U.S. Federal Reserve Chair Jerome Powell said "the economy is doing very well" *Goldman Sachs model now points to higher U.S. Q2 GDP growth of 4% *Google... Russia's biggest two banks, Sberbank and Alfa Bank, are planning to test several private banking products based on cryptocurrencies in a regulatory sandbox environment hosted by the Russian central bank, the Kommersant newspaper reported.
Follow RTT