References
Ozanimod for relapsing remitting multiple sclerosis and how Brexit changed the journey
Abstract
This article will focus on ozanimod, a medication that has been put forward for relapsing-remitting multiple sclerosis (RRMS). It will look at ozanimod's characteristics, including the pharmacokinetics and pharmacodynamics of the medication, and follow ozanimod's journey from clinical trials through the different licencing agencies, allowing ozanimod to be used as a treatment in multiple sclerosis (MS). Finally, this article will look at its journey through the National Institute for Clinical Excellence (NICE) to seek approval to be used as a medication to treat RRMS on the NHS. The article will also briefly reflect on the marketing authorisation changes in the UK since leaving the European Union (EU) and the impact of these changes.
Multiple sclerosis (MS) is an immune-mediated inflammatory condition that affects the central nervous system (CNS). The inflammatory process causes areas of demyelination, scarring and neuronal damage throughout the CNS, causing symptoms and accumulating progressive disability, which is dependent on the areas of the CNS that has been affected (MS Society, 2020).
In 1997, Beta-interferon 1a (Avonnex) was licenced in the European Union (EU) for RRMS to reduce the impact and disease process of MS. Today there is a mixture of tablets, injections and infusions available on the NHS for RRMS. It was hoped that Ozanimod would be added to this list and to be the first oral medication to be given after one relapse in 1 year (Comi et al, 2019).
Pharmacokinetics is a word that is used to describe how a medication passes through the body. This identifies the therapeutic effect of a medication and its safety profile by looking at the time and route the medication takes to be absorbed, distributed, metabolised and excreted (Surapaneni et al, 2021). This is important because certain factors can affect the absorption of a medication and therefore its effectiveness.
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