Siponimod gets TGA tick for SPMS

Multiple sclerosis

By Mardi Chapman

27 Nov 2019

Siponimod (Mayzent) has been TGA approved for the treatment of adults with secondary progressive multiple sclerosis (SPMS). 

The TGA approval is based on the results of the EXPAND study which found siponimod reduced the risk of disability progression.

The study, published in The Lancet last year, found siponimod reduced the number of confirmed disability progression events by 21% at three months and by 26% at six months. 

It’s safety profile was found to be similar to that of other sphingosine-1-phosphate receptor modulators.

Neurologist Associate Professor Anneke Van Der Walt from Monash University told the limbic there were 12 approved treatments for relapsing-remitting MS, but siponimod was the first treatment for SPMS.

“If we treat the inflammatory phase of MS early with good medications, then we can prevent or slow down any transition into SPMS,” she said.

“In Australia, where most people with MS would be on treatment, the number of people that would transition into SPMS would be more like 40%.”

She said because there had previously been no approved treatment for SPMS and because of some uncertainty about when patients might be entering SPMS, a lot of those patients remain on their disease modifying treatments for relapsing-remitting MS.

“The problem is transition is not that easy to pick up and what the approval of Mayzent will mean for people with MS is that doctors and neurologists may pay more attention to very subtle changes of progression because there is now a treatment approved for that situation.”

She said there was the need for a better way to pick up subtle changes in neurological function. 

“We are certainly looking at introducing new technology into clinics were we might be able to detect progression earlier. That could be monitoring memory function, upper limb function and walking speed which might be a better way of seeing subtle changes rather than waiting for someone to say they have developed a persistent weak leg because that can take decades.” 

With Mayzent becoming available, patients should be having a discussion with the neurologists to work out where they are in terms of their disease progression and whether Mayzent might be a better treatment for them than any treatment they might currently be on.”

The PBAC were scheduled to consider a submission for PBS listing of siponimod, an oral treatment, at its November meeting.

Already a member?

Login to keep reading.

Email me a login link