Siponimod approved in USA for treatment of Secondary Progressive MS

  • Siponimod, brand name Mayzent, has been shown in clinical trials to prevent relapses in people with clinically isolated syndrome (CIS) and relapsing remitting MS (RRMS)
  • A large clinical trial in people with secondary progressive MS (SPMS) showed that it was also able to reduce the risk of disability progression in those with SPMS who were still experiencing lesions and relapses (active SPMS)
  • The United States Food and Drug Administration (FDA) has approved the medication for use in relapsing forms of MS including active secondary progressive MS
  • The European Medicines Agency (EMA) is currently considering siponimod and we would also expect a submission to the Australian Therapeutic Goods Administration (TGA) in the near future.

The United States Food and Drug Administration (FDA) has issued an announcement that it has approved a new drug, siponimod, brand name Mayzent, to treat relapsing forms of MS – that includes clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive disease.

Active secondary progressive MS is when the disease enters a phase of gradually progressing disability, but there are still signs of active inflammation such as relapses or the appearance of new lesions in MRI scans. The approval of this medication to specifically include people with active secondary progressive MS is a very positive development to broaden treatment options for people living with progressive forms of MS.

This approval follows successful clinical trials showing that siponimod slowed disability progression and reduced inflammatory activity in people with secondary progressive MS.

Siponomod was tested against placebo (an inactive dummy tablet) in large international clinical trials. The largest (Phase 3) trial was conducted across 31 countries. When enrolled into the study, trial participants had MS for an average of 17 years, and were on average 48 years of age. Overall the results showed that the group that received siponimod had a significantly lower risk of disability progression compared to those that received the inactive tablets. However, when further analysis was carried out, it showed the sub-group of people with active SPMS had a stronger response than those who did not have relapses or lesions in the two years prior to entering the study.

The manufacturer, Novartis, has also applied for approval in Europe, with a decision expected later this year. We would fully expect a similar submission to the Australian Therapeutic Goods Administration (TGA) at some stage in the near to medium-term future. We will be keeping you fully updated on any developments.

Siponimod is an immune modulating drug, taken in tablet-form, once a day. You can read more about the trial results in our article here.

Professor Xavier Montalban, Chair of the International Medical and Scientific Board for the MS International Federation (MSIF), of which MS Research Australia is a member, commented:

“This is good news and another important step in our efforts to make sure that all types of MS can be treated effectively. Each new drug that is developed and approved not only gives us a new treatment option for people with MS; it helps us to understand MS better. Of course we still have much work to do, but piece by piece we are unravelling this disease and making strides towards our ultimate goal of stopping MS.”

Dr Matthew Miles, CEO at MS Research Australia, said: “Along with many other countries, Australians living with progressive MS participated in this important trial. It is very encouraging to see a renewed global fight against progressive MS starting to achieve some strong results. MS Research Australia firmly believes that MS needs to be stopped for all people living with MS and not just some. This is a positive move in that direction and we are determined to continue to be part of that global effort.”

Some of the MS medications currently available in Australia have been licenced by the TGA for relapsing MS and are used in people living with SPMS who continue to have signs of inflammatory lesions. We hope that the TGA provide a similarly broad use for siponimod for people living with SPMS in Australia.

What is vitally important however, is that any medications approved by the TGA for use in progressive forms of MS are also made affordably available to everyone via reimbursement on the Pharmaceutical Benefits Scheme (PBS). MS Research Australia will continue to advocate for this and for affordable access to any medication that has been shown in clinical trials to provide a clinical benefit. In particular, for people with progressive MS there is a very great and urgent need for any proven medication that can safely slow down the progression of the disease.|

For people with all forms of MS, the variability of the disease, the varying responses to treatments and every person’s individual life and health circumstances mean that a range of treatment options is crucial. Every person with MS and their healthcare team needs to be able to find the most appropriate and effective treatment option for them.


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Siponimod approved in USA for treatment of Secondary Progressive MS