Ozanimod (Zeposia) for the treatment of multiple sclerosis

Introduction

Ozanimod (trade name: Zeposia) has been approved in Germany since May 2020 for the treatment of active relapsing-remitting multiple sclerosis in adults.

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, , arm and leg pain, partial paralysis, dizziness and trembling.

MS can take on various forms:

  • Primary progressive MS (PPMS): In this rare type of MS, the symptoms constantly get worse, usually without any distinguishable episodes. In this form the symptoms do not go away.
  • Relapsing-remitting MS (RRMS): This type often comes in episodes, with symptom-free intervals between acute phases. Remitting means that after an episode, the symptoms will go away completely or at least get better. If many attacks occur within a short time, it is referred to as highly active relapsing-remitting MS. Relapsing MS can enter a phase in which the symptoms gradually get worse independently of the relapses, but then also don’t get better. That is referred to as secondary progressive MS (SPMS).

Ozanimod is an option for

  • the treatment of active RRMS that has not been previously treated or MS that has previously been treated and is not highly active.
  • the treatment of highly active RRMS that still causes increased relapses despite treatment.

Ozanimod lowers the number of white blood cells, which is supposed to have a positive effect on the disease.

Application

Ozanimod is available in capsule form in three doses: 0.23 mg, 0.46 mg and 0.92 mg. The daily dose is increased step by step from 0.23 mg to 0.92 mg. Ozanimod is taken once a day.

Other treatments

Various medications are available for the treatment of active RRMS in people who have not had previous treatment or in people who have already had treatment and who have multiple sclerosis that is not highly active. These include interferon beta-1a, glatiramer acetate and ocrelizumab.

If people with highly active RRMS experience an increase in flare-ups despite having treatment, they can use the drugs alemtuzumab, fingolimod or natalizumab too. It is also possible to switch from the basic treatment medications to interferon beta drugs or glatiramer acetate.

Assessment

In 2020, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether ozanimod has any advantages or disadvantages compared to the standard treatments for active RRMS.

The manufacturer provided IQWiG with usable data on the following groups:

  • People who have not had previous treatment or people who have already had treatment but don’t have a high level of disease activity
  • People who have already had treatment and have a high level of disease activity

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 ozanimod (Zeposia).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ozanimod (multiple sclerosis) – benefit assessment according to § 35a SGB V. Dossier assessment; Commission A20-59. October 13, 2020. (IQWiG reports; Volume 980).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Updated on November 5, 2020
Next planned update: 2023

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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