Introduction

Fingolimod (trade name: Gilenya) has been approved in Germany since March 2011 for adults with highly active relapsing-remitting multiple sclerosis (RRMS) if the standard treatment with interferon beta isn't effective enough or if the disease is progressing unusually quickly and severely. The drug has also been approved since May 2014 for people who have already had another disease-modifying treatment such as glatiramer acetate. A treatment is considered to be "disease-modifying" if it can positively influence the course of the disease. Since November 2018, it has also been approved for children and teenagers from the age of 10.

Multiple sclerosis (MS) is a chronic and incurable inflammatory disease of the central nervous system in which the body’s immune system damages nerve pathways in the brain and the spinal cord. This condition can cause abnormal sensations, fatigue, arm and leg pain, partial paralysis, dizziness and trembling. MS often comes in episodes, with symptom-free intervals between acute phases. This type is called relapsing-remitting multiple sclerosis (RRMS). If many attacks occur within a short time, it is referred to as highly active multiple sclerosis.

The disease is usually treated with interferon beta or glatiramer acetate to start off with. Drugs such as fingolimod, glatiramer acetate and interferon beta slow down damage to the nerve cells by affecting the immune system.

Application

Fingolimod is available in capsule form, in doses of 0.25 mg and 0.5 mg. Adults take one capsule (0.5 mg) once a day independently of meals.

The dose for children and teenagers depends on their body weight: Those who weigh 40 kilos or less take one 0.25 mg capsule a day, and those who weigh more than 40 kilos take one 0.5 mg capsule a day.

Other treatments

Several drugs are available for the treatment of highly active or rapidly evolving RRMS, the main ones being interferon beta and glatiramer acetate. The treatment is individually adjusted by a doctor.

Assessment

In 2016, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) again looked into whether fingolimod has any advantages or disadvantages compared to conventional standard treatments for adults with highly active RRMS. Depending on the stage of their disease and previous treatments, they were split up into several groups. There was enough suitable data for the following groups:

  • Adults in whom the disease stayed active despite complete and appropriate standard treatment.
  • Adults with rapidly evolving severe RRMS.

In 2019, IQWiG looked into whether fingolimod has any advantages or disadvantages for children and teenagers with highly active RRMS. The manufacturer didn’t provide any suitable data about children and teenagers with rapidly evolving severe RRMS. But there was suitable data about children and teenagers in whom the disease stayed active despite having appropriate standard treatment.

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More information

This information summarizes the main results of several reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the "early benefit assessment of medications." On the basis of these reviews and the hearings received, G-BA passed a resolution on the added benefit of fingolimod (Gilenya) for adults

and for children and teenagers.