BG-12 (Biogen) is filed at FDA and EMA for Multiple Sclerosis

FDA and EU regulatory authorities have accepted for review applications for BG-12 (dimethyl fumarate) from Biogen IDEC, an oral drug for Multiple Sclerosis. The FDA has 10 months to take action on the application, unless it requests additional time to complete the review.The European Medicines Agency has validated its marketing authorisation application for review of BG-12 in the European Union. An EMA review period for this type of filing takes 13 to 15 months. The product is also awaiting approval in Canada and Switzerland.