EMA grants new active substance to Tecfidera-Biogen IDEC

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has determined that dimethyl fumarate in Tecfidera qualifies as a new active substance (NAS). This designation will provide 10 years of regulatory exclusivity for Tecfidera in the European Union (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 treatment for adults with relapsing-remitting Multiple Sclerosis (RRMS). The CHMP�s determination will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the EU.

Tecfidera has patent protection in the EU to 2028 at a 480 mg dose, but the New Active Substance (NAS) label gives it data protection, and regulatory exclusivity from generics for ten years.