First treatment for people with secondary progressive MS in Europe is approved

The European Medicines Agency (EMA) has granted a licence for the drug Siponimod (brand name: Mayzent) to be used to treat some adults with secondary progressive MS.

This is the first oral treatment in Europe that is approved to treat secondary progressive MS.

Siponimod was licensed by the US Food and Drug Administration in the United States in March 2019.

Professor Brenda Banwell, Chair of the International Medical and Scientific Board for the MS International Federation, commented:

“The EMA’s approval of siponimod is another important milestone in improving the treatment of progressive MS.

“Siponimod not only expands the treatment options. In some countries it expands the range of people who we can offer treatment to. We still have a lot of work to do to really beat MS, but we are making progress.”

Who can take the drug?

Siponimod hasn’t been licensed for everyone with secondary progressive MS in Europe though. It has only be granted for people with active MS. This means people who still have relapses or who have evidence of inflammatory activity on an MRI scan.

Decisions about availability, price and reimbursement will now be made at a national level by each member state across Europe.

What is siponimod and how do you take it?

Siponimod is an immune modulating drug, taken as a tablet, once a day.

Not all countries allow drugs that have been approved for relapsing MS to also be used to treat secondary progressive MS. Siponimod could provide a new treatment option for those living with active secondary progressive MS.

The clinical trials tested siponimod against placebo, not against other treatments. The largest (phase 3) trial was conducted across 31 countries.  When enrolled into the study, trial participants had been living with MS for an average of 17 years, and had an average age of 48.