Tecfidera approved in the European Union as a first-line oral treatment for multiple sclerosis


Tecfidera (dimethyl fumarate) has been approved by the European Commission as a first-line oral treatment for people with relapsing-remitting multiple sclerosis.

According to a press release issued by Tecfidera manufacturer, Biogen Idec, the European Commission approval is based on a robust clinical development programme that included two global phase 3 clinical trials, DEFINE and CONFIRM, as well as an ongoing extension study, ENDORSE, in which some patients have been followed for up to six and a half years. Tecfidera has been clinically shown to significantly reduce important measures of disease activity, including relapses and the development of brain lesions, as well as to slow disability progression, while demonstrating a favourable safety and tolerability profile.

Eli Silber, consultant neurologist at the King’s Regional Neurosciences Centre, London says, “Given that the average age of onset of the disease is in the early thirties, we are looking at a long disease course and considerable effects on work and family life. Tecfidera has the advantage of being a capsule and is an efficacious and convenient oral therapy. Multiple sclerosis is a long term condition and we are looking at long term therapies to prevent disease progression. Any new treatment that is effective and that makes the treatment process convenient for patients is welcome.” 

Tecfidera was first approved in the USA in March 2013, and approved in Canada and in Australia later that year.