Introduction

Fingolimod (trade name: Gilenya) has been approved in Germany since March 2011 for the treatment of highly active relapsing-remitting multiple sclerosis (RRMS) that has not responded sufficiently to standard interferon beta therapy or that is developing unusually quickly and severely. The drug has also been approved since May 2014 for people who have already had another disease-modifying therapy such as glatiramer acetate. A therapy is called disease-modifying if it can have an advantageous effect on the course of the disease.

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, 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 condition 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

The drug is taken once a day in capsule form (0.5 mg) independently of meals.

Other treatments

Several drugs are available for treating highly active or rapidly evolving RRMS, the main ones being interferon beta and glatiramer acetate.

Assessment

In 2016, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) examined whether fingolimod offers an added benefit over conventional standard therapies for people with highly active RRMS. Depending on the state of their disease and previous treatments, several groups were formed. IQWiG assessed fingolimod for the following groups of patients:

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

Regarding people who had completed treatment with interferon beta the manufacturer did not provide suitable data for a comparison with fingolimod. So it was not possible to show any advantages or disadvantages of fingolimod over standard therapy for this group.

Enough data was available to complete assessment for the following groups:

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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).

You will find general information about this medication and possible side effects in the package insert and various safety warnings.

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