Introduction

Dimethyl fumarate (trade name: Tecfidera) has been approved in Germany since January 2014 for adults with relapsing-remitting multiple sclerosis.

Multiple sclerosis (MS) is a chronic and incurable inflammatory disease of the central nervous system, in which the body’s own immune system damages nerve pathways in the brain and spinal cord. This condition can cause abnormal sensations, fatigue, arm and leg pain, spasms, paralysis, dizziness and trembling. In some cases, parts of the muscular system tense up permanently.

Dimethyl fumarate is intended for people with relapsing-remitting (remitting = recovering) multiple sclerosis, also called RRMS. This form of multiple sclerosis is characterized by relapses (periods when the condition returns) occurring over and over. The physical symptoms go away completely or nearly completely between relapses.

Application

Dimethyl fumarate is available in two different doses: 120 or 240 milligrams. It is taken twice a day with meals in 120 milligram tablets during the first week of treatment. The dose is then increased to 240 milligrams twice a day after seven days.

Other treatments

The drugs interferon beta (1a or 1b) or glatiramer acetate are common therapies for treating multiple sclerosis.

Assessment

In 2014, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) examined whether dimethyl fumarate offers an added benefit over the conventional standard therapy.

The manufacturer did not provide any data suitable for answering this question.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the "early benefit assessment of medications." On the basis of this review and the hearings received, G-BA passed a resolution on the added benefit of dimethyl fumarate (Tecfidera).

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