Health Canada approves siponimod for treatment in adults with active secondary progressive MS

Health Canada has approved Mayzent® (siponimod) for the treatment of adults with active secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features characteristic of multiple sclerosis inflammatory activity, to delay the progression of physical disability. Mayzent® (siponimod) is marketed by pharmaceutical company Novartis International AG.

Siponimod works by entering the central nervous system (CNS) and preventing harmful immune cells – specifically B cells and both CD4+ and CD8+ T cells – from being activated and released from the lymph nodes and thymus gland into the central nervous system.

The Health Canada approval of siponimod was based on the EXPAND study, a phase III clinical trial that enrolled 1,645 people from 31 countries between the ages of 18 to 60 with SPMS and an Expanded Disability Status Scale (EDSS) score of 3.0–6.5. Data from EXPAND showed that siponimod met its primary endpoint of reduced risk of three-month confirmed disability progression (CDP) by 21% versus placebo. Siponimod also resulted in reduced six-month CDP by 26%. On imaging measures, siponimod slowed the rate of brain volume loss by 23% and decreased T2 lesion volume by approximately 80% over 12 and 24 months and reduced annualized relapse rate (ARR) by 55%. See here for additional data reported from the EXPAND study.

Reimbursement of siponimod by Canadian federal, provincial and territorial governments will depend on several factors and will be informed by the Common Drug Review conducted by the Canadian Agency for Drugs and Technologies in Health (CADTH). Quebec conducts an independent review through the Institut national d’excellence en sante et en services sociaux (INESS). The MS Society will provide updates related to reimbursement as they become available. Individuals interested in treatment with siponimod are encouraged to speak with their MS healthcare team.