Siponimod could be the first oral disease modifying treatment (DMT) licensed in the UK for secondary progressive MS.
The Committee for Medicinal Products for Human Use has recommended siponimod is approved as a treatment for people with active secondary progressive MS.
Siponimod (brand name Mayzent) is taken as a daily tablet.
What does this decision mean?
This is an exciting step forward for MS treatment. It means the drug is very likely to be licensed by the European Medicines Agency very soon.
When will siponimod be available?
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, and we don't expect a decision until the middle of 2020.
NICE is in the early stages of considering siponimod for use in England and Wales already.
We expect the Scottish Medicines Consortium and Department of Health in Northern Ireland to carry out similar assessments too.
Who can get siponimod?
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 and/or still have relapses.
There may be further restrictions like how long you've had MS for, and level of your disability. We won’t know these in full until the license is published.
What’s the evidence?
Research found siponimod can reduce the risk of disability progression by 21% compared with a placebo. Siponimod also significantly reduced the rate of brain atrophy (shrinkage) and the number of relapses people experienced.
'An important first step’
Genevieve Edwards, our Director of External Affairs, said: “This exciting step forward means siponimod could become the first oral DMT licensed for active secondary progressive MS. The drug provides a much needed option for people with secondary progressive MS to take control of their condition. Once licensed, the next challenge is making sure siponimod is available on the NHS to everyone who could benefit.
“Because siponimod only works on the immune system it won’t help everyone with secondary progressive MS – just those still experiencing relapses. We can see a future where nobody needs to worry about their MS getting worse, but we need drugs that repair myelin and protect the nerves from damage. Through our Stop MS Appeal, we hope to raise £100 million to find treatments for everyone with MS.”