CHMP Determines Dimethyl Fumarate in TECFIDERA to be a New Active Substance in the EU

Biogen Idec has reported that 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 authorisation in the EU for TECFIDERA as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). CHMP’s determination will now be referred to the European Commission (EC), which grants marketing authorisation for medicines in the EU.

“We are heartened by the CHMP’s NAS determination, which brings us closer to our goal of providing this important new treatment to multiple sclerosis (MS) patients in Europe. We are ready to introduce TECFIDERA in EU countries shortly after anticipated approval,” said Douglas Williams, PhD, Executive Vice President of Research and Development at Biogen Idec. “This designation validates the tremendous investment we have made in TECFIDERA and enables us to invest in future research focused on reversing the course of MS and hopefully one day finding a cure for patients.”

If approved, TECFIDERA will mark the fourth therapy that Biogen Idec offers to people living with MS in the EU.