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Siponimod licensed for secondary progressive MS

Today the European Medicines Agency (EMA) granted a license for siponimod (brand name Mayzent) to treat adults with secondary progressive MS with active disease.

That makes siponimod the first and only oral treatment in Europe specifically for patients with secondary progressive MS with active disease.

What was the evidence?

The drug approval is based on the Phase III EXPAND trial, the largest randomised clinical study of people with secondary progressive MS.

This trial showed taking siponimod significantly reduced the risk of disease progression, including physical disability and cognitive effects.

Who can have siponimod (Mayzent)?

Siponimod hasn't been recommended for everyone with secondary progressive MS. It's only been recommended for people who have evidence of inflammatory activity on an MRI scan or who still have relapses.

How does siponimod (Mayzent) work?

Siponimod works in a similar way to the licensed treatment fingolimod. It's taken as a daily tablet.

It traps certain types of immune cell (called B and T cells) in the body's lymph nodes. This stops them from getting into the brain and spinal cord, where they could cause damage to the protective myelin coating around the nerve.

Landmark announcement

Jonathan Blades, our Head of Campaigns and External Relations said:

“This is a landmark moment our community has waited a long time for. More than 100,000 of us live with MS in the UK and those with progressive forms have had very few, if any, options to improve their condition.

"People transitioning from relapsing to secondary progressive MS face an equally impossible challenge – being forced to go from having a range of treatments available to them, to severely limited choices.

Today's news offers hope to thousands with MS

“Today’s news offers immense hope to thousands living with secondary progressive MS who have been desperate for something to better their quality of life. We can see a future where nobody needs to worry about MS getting worse, and this shows what an exciting time it is for MS research.”

Explore the research behind the decision in the siponimod treatments in trials page. Or read about other treatments on our disease modifying therapy (DMT) pages.

What next?

The next step is for UK health bodies to decide whether siponimod should be available on the NHS. We’ll be working hard to make sure that happens as soon as possible. But the process can take some time. Find out more about the journey from lab to pharmacy shelf.

The National Institute for Health and Care Excellence (NICE) are assessing siponimod to see if it's cost effective for England and Wales. They'll consider evidence from our MS community we submitted together last year.

We expect the Scottish Medicines Consortium and Department of Health in Northern Ireland to carry out similar assessments too.

We expect them to publish their findings in the next few months. Meantime we'll keep campaigning for the right treatment at the right time for everyone with MS.

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