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Ozanimod

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  1. Summary
  2. Licensing and appraisal
  3. How does ozanimod work?
  4. How is ozanimod taken?
  5. Ozanimod research
  6. Side effects

Other names: RPC-1063, Zeposia

Summary

Ozanimod is a new drug treatment under investigation for relapsing remitting multiple sclerosis (MS).  It is taken as a tablet once daily.

Ozanimod for relapsing remitting MS: Appraisal

NHS appraisal

  • Ozanimod causes lymphocytes to be retained in lymph glands
  • In relapsing remitting MS, ozanimod reduced relapse rates by approximately 38% compared to beta interferon
  • In phase III studies, the most common side effects were colds, headache, chest infections and urinary tract infections

Licensing and appraisal

Licensing

The European Commission has approved ozanimod (Zeposia) for people with active relapsing remitting MS. Active is defined as people who are having relapses or have new or enlarging lesions on MRI scans.

This follows the European Medicines Agency (EMA) recommendation in April 2020.

Appraisal

NICE has begun an appraisal of ozanimod for relapsing remitting MS. In its draft recommendation, NICE does not consider ozanimod to be cost-effective for the NHS in England and Wales. This is NICE’s initial decision and they have asked the manufacturer for more detailed evidence and analysis of the data. The MS Trust has been taking part in the appraisal and we will be responding to NICE's decision.

If you wish to comment on the draft recommendation, you can do so through the NICE website by 5pm, 12 February 2021.

The Scottish Medicines Consortium has also started an appraisal for the use of ozanimod and the MS Trust will also be contributing.

How does ozanimod work?

Ozanimod belongs to the same class of drugs as Gilenya (fingolimod) and Mayzent (siponimod).

It acts on certain types of white blood cells (lymphocytes) which are involved in the autoimmune attack on myelin seen in MS. It binds to special locations (or receptors) on the surface of the lymphocytes, called sphingosine-1-phosphate receptors (S1P-R). This causes a larger proportion of lymphocytes to be retained in the lymph glands. The number of activated lymphocytes reaching the brain is decreased, resulting in reduced immune attack on nerve cells in the brain and spinal cord.

How is ozanimod taken?

Ozanimod is taken as a tablet, once daily.

Ozanimod research

What are the results so far?

In a phase II study, 258 people with relapsing remitting MS took one of two doses of ozanimod or placebo for 24 weeks.  The main measure was the number of new active lesions seen on MRI.  Ozanimod significantly reduced the number of lesions compared to placebo. 

  • SUNBEAM - ozanimod compared to  interferon beta 1a (Avonex)

1346 people with relapsing MS were recruited to this phase III study.  Participants took one of two doses of ozanimod or interferon beta 1a (Avonex) for one year.  For the group taking 0.5mg ozanimod, the annual relapse rate was 0.24, a 31% reduction compared to Avonex. For the group taking 1.0mg ozanimod, the relapse rate was 0.18, representing a 48% reduction compared to Avonex.

Compared to Avonex, both doses of ozanimod also significantly reduced the number of new active lesions seen on MRI.  Changes in brain volume were not significantly different between the two doses of ozanimod and Avonex.

  • RADIANCE - ozanimod compared to interferon beta 1a (Avonex)

This phase III study recruited 1320 participants with relapsing MS who took one of two doses of ozanimod or interferon beta 1a (Avonex) for two years.  The main aim of the study was to compare relapse rates for ozanimod and Avonex.   For the group taking 0.5mg ozanimod, the annual relapse rate was 0.22, a 21% reduction compared to Avonex.  For the group taking 1.0mg ozanimod, the relapse rate was 0.17, a 38% reduction compared to Avonex.   Compared to Avonex, both doses of ozanimod also significantly reduced the number of new active lesions seen on MRI.  Both doses also reduced brain volume loss compared to Avonex.

Side effects

The most common side effects reported in the phase III studies were nasopharyngitis (common cold), headache, chest infections and urinary tract infections.  Ozanimod caused caused temporary increases in liver enzymes which generally returned to normal levels without the need to stop treatment.

References

  • Cohen JA, et al. Safety and efficacy of the selective sphingosine 1-phosphate receptor modulator ozanimod in relapsing multiple sclerosis (RADIANCE): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2016;15(4):373-81. Abstract
  • Cohen JA, et al. Efficacy and safety of ozanimod in multiple sclerosis: Dose-blinded extension of a randomized phase II study Mult Scler 2018 Jul 25; 1352458518789884 [Epub ahead of print] Full article
  • Comi G, et al. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial Lancet Neurology 2019; Sept 3 [Epub ahead of print] Abstract
  • Cohen JA, et al. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial. Lancet Neurology 2019; Sept 3 [Epub ahead of print] Abstract
  • Swallow E, et al. Comparative safety and efficacy of ozanimod versus fingolimod for relapsing multiple sclerosis. J Comp Eff Res. 2020 Jan 17. doi: 10.2217/cer-2019-0169. [Epub ahead of print] Full article
Drugs in development

Drugs in development

New MS medications can take years in development until they reach us. Find out about new drugs on the horizon for MS.

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