Novartis receives FDA approval for Mayzent (siponimod), the first oral drug to treat secondary progressive MS with active disease
- Mayzent (siponimod) is the first and only treatment specifically approved for patients with active secondary progressive multiple sclerosis (SPMS) in over 15 years[1]
- Up to 80% of patients with relapsing remitting MS (RRMS) will develop SPMS[2]; Mayzent addresses a critical unmet need for RRMS patients in transition and those with active SPMS who have transitioned??
- Approval is based on the Phase III EXPAND trial, the largest controlled clinical study of SPMS patients, showing Mayzent significantly reduced the risk of disease progression, including impact on physical disability and cognitive decline[3]?
- Mayzent is approved across the MS spectrum for clinically isolated syndrome (CIS), RRMS and active SPMS, with most patients not requiring a first dose observation