Biogen Gets Data Protection in EU

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 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 is approved in the U.S., but was delayed in Europe because of data issues. Dimethyl fumarate, the API in Tecfidera, is used in Fumaderm, a psoriasis drug marketed by Biogen Idec. The MS treatment uses a different formulation of that generic API, and the issue of data protection was seen as a deal-breaker for Tecfidera reaching the EU market.