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
Reports that Gary Cohn is considering resigning as President Donald Trump's top economic advisor have weighed on Wall Street, although the White House has denied the claims. Cohn, former president and chief operating officer of Goldman Sachs (GS), currently serves as the Director of the National Economic Council. A Pennsylvania woman has sued Chick-fil-A after she claimed a dead rodent was found baked into her chicken sandwich. Ellen Manfalouti of Northampton has filed a lawsuit in Bucks County Court against Chick-fil-A, seeking more than $50,000 for the physical and psychological damages that she endured after the incident occurred. Early Uber investor Shervin Pishevar has alleged that venture capital firm Benchmark Capital is seeking to remove Arianna Huffington from the ride-hailing company's board of directors. Pishevar also accused Benchmark of holding Uber hostage by threatening to block investments in the company and urged it to step down from Uber's board of directors.
comments powered by Disqus
Follow RTT