The Therapeutic Goods Administration has approved Mayzent for the treatment of adults with secondary progressive multiple sclerosis (SPMS), says Novartis.
The registration addresses a critical unmet need, the company says, and makes Mayzent (siponimod) the first and only approved oral treatment for adults with SPMS in Australia.
The condition follows an initial form of relapsing remitting MS (RRMS).
It is estimated that up to 80 per cent of patients with RRMS will eventually transition to SPMS, which is characterised by cognitive and physical changes and an overall accumulation of disability.
The TGA approval of Mayzent is based on the results of the Expand Phase III study, the largest controlled clinical study of patients with SPMS, published in the Lancet in 2018. Novartis has already made a submission to the November meeting of the PBAC for reimbursement on the PBS, and awaits an outcome in December.
Multiple sclerosis (MS) is a chronic disorder of the central nervous system that affects over 25,600 Australians and more than two million people worldwide.
“One of the most important aims of MS treatment is delaying disability progression and preserving cognition,” said Neurologist Associate Professor Anneke Van Der Walt.
Most patients transition from RRMS to SPMS over time. Therefore, maintaining regular conversations about SPMS is critical for patients and physicians to help identify the early stages of disability progression.
Disability progression frequently includes difficulty walking and the need for mobility aides, cognitive and work-related issues and bladder dysfunction.
“TGA approval of an SPMS therapy should encourage healthcare professionals to support early identification and management of SPMS by prompting a discussion to uncover the signs of progression,” neurologist Professor Michael Barnett said.
Novartis says it is committed to ensuring patient access to Mayzent and will work closely with all stakeholders to help improve the lives of Australians living with MS.