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Siponimod licensed in US for active secondary progressive MS

This week the US Food and Drug Administration (FDA) has approved siponimod, a daily tablet, as a treatment for adults with relapsing forms of MS. This includes active secondary progressive MS.

This is the first licensed treatment for secondary progressive MS in over 15 years.

What does this mean?

This is good news. We are now one step closer to having another effective disease modifying therapy (DMT) for people living with secondary progressive MS available on the NHS.
Before the NHS can consider the drug, it will need to be considered safe and effective (‘licensed’) by the European Medicines Agency (EMA). We expect a decision by the EMA towards the end of 2019.

A positive step for secondary progressive MS treatments

Phil Anderson, Head of Policy, MS Society said: “The FDA announcement marks a positive step towards better treatment options for people with secondary progressive MS. We hope to see UK regulators prioritise access to siponimod on the NHS as soon as the opportunity arrives, so everyone who could benefit from this therapy is able to.

“MS can be painful and exhausting, and those living with secondary progressive MS have waited long enough to have genuine choice when it comes to treatment decisions.”

What’s the evidence?

Approval by the FDA was based on the results of the Phase III EXPAND trial, published in the Lancet in March 2018. This was the largest ever trial of secondary progressive MS patients. It showed that siponimod had a modest but significant effect on reducing the risk of disease progression, including impact on physical disability and cognitive decline.

Researchers found that 26% of people on siponimod experienced a worsening of disability while on the trial, compared to 32% who took a placebo.

Generally, siponimod was well tolerated, but like other DMTs, some people did experience side effects. These ranged from minor side effects like runny noses, to more serious conditions, like high blood pressure and low white blood cell count.

Read more about the research into siponimod

Who can receive siponimod in the US?

The conditions of the FDA licence mean siponimod, (brand name Mayzent) can be prescribed in the US for:

  • people with secondary progressive MS who have evidence of inflammatory activity on an MRI scan and/or with relapses
  • people with relapsing-remitting MS
  • people with clinically isolated syndrome (a first episode of neurological symptoms that lasts at least 24 hours).

Other factors that will be taken in consideration are someone’s level of disability and how long they have lived with MS symptoms.

On average, people participating in the EXPAND trial had only had secondary progressive MS for less than 4 years. And some still had relapses during the trial. It’s still unclear whether siponimod can help people who've had secondary progressive MS for many years.

The participants of the trials were people living with Expanded Disability Status Scale (EDSS) scores of 3.0 to 6.5. EDSS scores are used by researchers to measure disability progression.

An EDSS score above 6.5 indicates disability that requires the use of a wheelchair, so people who use wheelchairs are not eligible for siponimod under the FDA decision.Read the full research paper on the Lancet website