New Treatment Approved for Active SPMS

It was announced earlier today that Mayzent (siponimod) has received US FDA approval for the treatment of adults living with relapsing multiple sclerosis (MS).  Importantly, this also includes people living with secondary progressive MS (SPMS) with active disease.  This is significant as this is the first treatment to have received approval in the past 15 years specifically for people living with active SPMS.

Mayzent is thought to be useful in the treatment of multiple sclerosis for two reasons.  Firstly, it has been shown to prevent cells of the immune system (known as lymphocytes) from leaving the lymph nodes and travelling to the central nervous system (CNS).  As it is thought that these cells are responsible for causing a lot of the nerve damage seen in multiple sclerosis, this helps to stop this damage from occurring.  Mayzent has also been found to interact with cells in the CNS, specifically oligodendrocytes and astrocytes.  By doing this, it is thought that Mayzent can both decrease inflammation and help promote remyelination.

This approval is the result of positive findings being generated in a Phase 3 clinical trial, known as the EXPAND study.  The study included 1651 people living with secondary progressive multiple sclerosis.  The results showed that:

• Fewer participants in the group that received Mayzent had progression of disability when compared to those in the placebo group
• Treatment with Mayzent caused a reduction in the number of relapses
• These statistically significant results were only observed for people living with SPMS that had active disease and not in those with non-active disease

In their statement about the release, Novartis has said that they expect regulatory action for Mayzent to occur in Europe, Japan, Australia and Canada later this year.

You can read more about this decision through the following links:

FDA Approval Announcement:  https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634469.htm

Novartis Approval Announcement:  https://www.novartis.com/news/media-releases/novartis-receives-fda-approval-mayzent-siponimod-first-oral-drug-treat-secondary-progressive-ms-active-disease