April 10, 2019

Breaking News: FDA approves siponimod for treatment in adults with active secondary progressive MS

March 29, 2019: The U.S. Food and Drug Administration (FDA) announced the approval of Mayzent® (siponimod) as a first-line treatment in adults with active secondary progressive MS, relapsing-remitting MS and clinically isolated syndrome (CIS), or an initial neurological event. The drug 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 FDA 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.

Novartis has submitted a drug marketing application for siponimod to Health Canada. It is currently under review. The MS Society will continue to provide updates on Health Canada approval and drug access as they become available.