Biogen Idec, Inc. (Massachusetts) (BIIB) Release: US and EU Regulatory Authorities Accept Oral BG-12 Marketing Applications for Review
5/10/2012 10:52:15 AM
WESTON, Mass.--(BUSINESS WIRE)--Today Biogen Idec (NASDAQ: 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 (MS). The U.S. Food and Drug Administration (FDA) has accepted Biogen Idec’s New Drug Application (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 (EMA) has validated Biogen Idec’s Marketing Authorisation Application (MAA) for review of BG-12 in the European Union.