Biogen Idec’s Tecfidera receives NAS designation from CHMP

Biogen Idec's new multiple sclerosis therapy Tecfidera has been designated as a new active substance (NAS) by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

This status will provide ten years of regulatory exclusivity for Tecfidera in the EU if it is ratified by the European Commission. The CHMP previously recommended the drug for approval in March 2013.

A first-line oral treatment for adults with relapsing-remitting MS, the drug will become the fourth Biogen Idec therapy for MS to be released in Europe when it launches.

It is believed that Tecfidera provides a new approach to treating MS by activating the Nrf2 pathway, although its exact mechanism of action is unknown.

Dr Douglas Williams, executive vice-president of research and development at Biogen Idec, said: "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."

Earlier this month, the company announced positive clinical trial data for Eloctate, the new haemophilia A therapy it has developed alongside Swedish Orphan Biovitrum.