The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has determined that dimethyl fumarate in Biogen Idec‘s MS treatment Tecfidera (dimethyl fumarate) qualifies as a new active substance (NAS). This designation will provide 10 years of regulatory exclusivity for Tecfidera in the EU. The NAS determination follows a positive opinion by the CHMP in March 2013 recommending marketing authorization in the EU for Tecfidera as a first-line oral treatmen...