- A new oral treatment for relapsing MS has been approved by the TGA in Australia.
- Ozanimod will be marketed under the trade name Zeposia.
- This treatment is in the same class as the medications fingolimod (Gilenya) and siponimod (Mayzent) and blocks immune cells in the body from going to the brain.
- An application to have this treatment included in the PBS will be resubmitted, following a previous submission to have this medication subsidised by the PBS that was deferred until this TGA approval.
On the 16th July 2020, ozanimod was approved by the Therapeutic Goods Administration (TGA) for the treatment of adults with relapsing forms of MS in Australia. Ozanimod will be marketed under the tradename Zeposia. Earlier this year (March 2020) the U.S. Food and Drug Administration (FDA) also approved ozanimod for use in people with relapsing forms of MS.
Ozanimod is an oral treatment that has a similar mode of action to fingolimod (Gilenya) and siponimod (Mayzent), medications that are already approved in Australia for the treatment of MS. Siponimod was also recently the first drug in Australia to be approved for the treatment of secondary progressive MS (SPMS) (more information available here), but at this stage in Australia, ozanimod has not been approved for secondary progressive disease.
Drugs in this class act by keeping a type of immune cell called lymphocytes in the lymph nodes. They do this by targeting a class of molecules found on the surface of cells called the sphingosine-1-phosphate (S1P) receptors. It is thought that this prevents them from moving from other parts of the body into the brain and spinal cord, and causing the damage seen in MS. This process is very important in MS relapses. While fingolimod targets all five of the S1P receptors, ozanimod and siponimod are more selective, which leads to fewer side effects.
Recent phase 3 clinical trials of ozanimod showed that the number of relapses per year, the number of new or active lesions, and brain volume loss (atrophy) were significantly lower in people treated with ozanimod compared to the comparison drug, interferon-beta. The most common side effects were nose and throat inflammation, headache, and upper respiratory tract infection. Further information about the results of clinical trials of ozanimod can be found here.
Dr Julia Morahan, Head of Research at MS Research Australia, said “This is great news for Australians living with relapsing MS. It expands the range of oral treatment options for the MS community in Australia, and we welcome this decision from the TGA”.
Ozanimod has been submitted for recommendation to be reimbursed under the Australian Pharmaceutical Benefits Scheme (PBS). MS Research Australia has been involved in advocating for its inclusion on the PBS. The Pharmaceutical Benefits Advisory Committee (PBAC) deferred their decision until after ozanimod had received approval for use from the TGA, which has now occurred. We are hopeful for a positive PBAC recommendation because, if approved, it will allow people with relapsing MS across Australia to access this new treatment option under the PBS.
It is important that individuals with MS discuss any new treatment options with their neurologist or health care professional as ozanimod is not suitable for everyone. We expect ozanimod to be available for supply in Australia soon.