- The first-ever treatment for secondary progressive MS (SPMS), a form of MS that can follow on from relapsing remitting MS (RRMS), has been approved in Australia.
- Siponimod will be marketed under the trade name Mayzent.
- This oral treatment is in the same class as relapsing remitting medication fingolimod (Gilenya) and targets immune cells.
- A parallel submission has also been made to the Pharmaceutical Benefits Advisory Committee (PBAC) for reimbursement under the Pharmaceutical Benefits Scheme (PBS).
Secondary progressive MS (SPMS) is a type of MS that can follow on from the most common form of MS, relapsing remitting MS (RRMS). Rather than experiencing symptoms that come and go, SPMS involves the slow accumulation of disability over time. Today, the Therapeutic Goods Administration (TGA) has approved siponimod (Mayzent) as the first ever treatment for this form of MS in Australia.
At their November meeting, the TGA approved siponimod for adults with SPMS. This follows the approval for siponimod in the US by the Food and Drug Administration (FDA) for use in people with RRMS and active SPMS (see our article here)
Siponimod is an oral treatment in the same class as fingolimod (Gilenya), a medication already approved in Australia for the treatment of RRMS. It acts by targeting immune cells and preventing them from moving into the areas of inflammation in MS (the brain and spinal cord). Clinical trials into siponimod showed a reduction in disability progression when compared to a mock treatment (placebo). People were treated for up to three years and disability progression was tracked every three months to see if siponimod had an effect.
The results showed that siponimod reduced disability progression, slowed brain tissue loss (atrophy), and reduced the number of new lesions. There were some side effects of the treatment, including reduced white blood count as well as cardiac and liver abnormalities, which were consistent with other MS treatments in this class (see our article here).
“This is wonderful news for Australians living with secondary progressive MS”, said Dr Matthew Miles, Chief Executive Officer of MS Research Australia, “This is a landmark in the treatment of this form of MS for Australians and we welcome this decision from the TGA”.
In a parallel submission, siponimod is also being considered for reimbursement under the Australian Pharmaceutical Benefits Scheme (PBS) during November (more information here). This decision is expected soon. If approved, it will then allow people with SPMS across Australia to access this new treatment option under the PBS.
MS Research Australia has been involved in advocating for its inclusion on the PBS, as this is the first treatment approved for use in SPMS. Making it affordable is vital so people who can benefit from it have affordable access, allowing them to reduce the impact of MS on their lives.
It is important that individuals with MS discuss any new treatment options with their neurologist as it is not suitable for everyone.