Novartis’s Mayzent (siponimod) has been approved by Australia’s Therapeutic Goods Administration (TGA) for the treatment of secondary progressive multiple sclerosis (SPMS), making it the first therapy to be approved for this use in Australia.
An orally administered treatment, Mayzent is in the same class of therapies as Gilenya (fingolimod), which is already approved in Australia for the treatment of RRMS. Gilenya also is marketed by Novartis.
Mayzent is designed to treat MS by targeting immune cells and stopping them from moving into the brain and spinal cord. That reduces the inflammatory process that promotes MS development and progression.
The TGA approved Mayzent for adults with SPMS at its November meeting. The decision follows the approval of Mayzent by the United States’s Food and Drug Administration (FDA) in March for use by people with RRMS and active SPMS.
Clinical trials on Mayzent, including the EXPAND Phase 3 clinical trial (NCT01665144), showed that treatment with Mayzent led to a reduction in disability progression when compared with treatment with placebo. EXPAND enrolled 1,651 people with SPMS who had evidence of disability progression in the prior two years and no relapses in the three months prior to enrollment.
Results from these studies indicate that Mayzent reduced disability progression, slowed down loss of brain tissue, and reduced the amount of new lesions.
Regarding safety, Mayzent treatment was associated with some side effects, including decreased white blood cell count and cardiac and liver problems. However, these adverse effects are in line with those observed in other MS treatments in this class of therapies.
“This is wonderful news for Australians living with secondary progressive MS,” Matthew Miles, CEO of MS Research Australia, said in a press release. “This is a landmark in the treatment of this form of MS for Australians and we welcome this decision from the TGA.”
In parallel, Novartis submitted an application to the Pharmaceutical Benefits Advisory Committee (PBAC) to consider Mayzent for reimbursement under the Pharmaceutical Benefits Scheme (PBS). PBAC is meeting in November to discuss the addition of Mayzent to PBS.
The decision for reimbursement is expected soon. Once approved, it would allow Australian patients with SMPS to access this new treatment under the PBS.
According to MS Research Australia, making Mayzent affordable is important so that people can have access to this first approved treatment in the country for SPMS. Being able to get this medication will allow patients to lessen the impact MS has on their lives.
In related news, the European Committee for Medicinal Products for Human Use (CHMP) also issued a recent opinion supporting Mayzent as an oral treatment specifically for adults with active SPMS in the E.U.