Biogen Idec (BIIB) announced that U.S. and EU regulatory authorities have accepted the company's marketing applications for the review of BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of multiple sclerosis or MS.
Biogen noted that the U.S. Food and Drug Administration or FDA has accepted the company's New Drug Application or NDA for marketing approval of BG-12 in the United States and granted the company a standard review timeline.
In addition, the European Medicines Agency or EMA has validated Biogen Idec's Marketing Authorisation Application or MAA for review of BG-12 in the European Union.
Biogen Idec said its regulatory applications for BG-12 were based on a comprehensive clinical development program in which BG-12 demonstrated significant reductions in MS disease activity coupled with favorable safety and tolerability in two pivotal Phase 3 clinical trials.
Biogen Idec announced that it submitted an NDA to the FDA and an MAA to the EMA in the first quarter of 2012. The company also recently submitted regulatory applications in Canada and Switzerland.
For comments and feedback contact: editorial@rttnews.com
Business News
April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.