Dimethyl fumarate to treat multiple sclerosis

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The European Commission granted a marketing authorization valid throughout the European Union for Tecfidera (dimethyl fumarate) on 30 January 2014. Dimethyl fumarate is a nervous system drug (N07XX09), that primarily acts by triggering the activation of the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) transcriptional pathway and has been shown in studies to reduce the inflammation and modulate the activity of the immune system. It is used to treat multiple sclerosis (MS), a disease in which inflammation destroys the protective sheath around the nerves. It is used specifically in adults with a type of MS known as relapsing-remitting MS, where the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions). In the main study involving 1,234 patients, Tecfidera has been shown to reduce the number of relapses in patients with relapsing-remitting MS and to reduce the number of patients who have them (27% relapsed vs 46% in placebo or dimethyl fumarate respectively). The authorization is for oral capsules of 120 and 240 mg.

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