Biogen’s multiple sclerosis drug gains further patent protection

Biogen's multiple sclerosis drug Tecfidera has received a further 10 years of regulatory exclusivity in the European Union (EU).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) determined that Tecfidera (dimethyl fumarate) qualifies as a new active substance (NAS) and therefore gains patent protection.

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.

"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. 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."

Douglas Williams, Ph.D., executive vice president of Research and Development at Biogen Idec.

An estimated 2,500,000 people in the world have multiple sclerosis. If approved, Tecfidera will mark the fourth therapy that Biogen offers to people living with MS in the European Union.