3 March 2020 - Approval is based on the Phase III EXPAND trial, the largest controlled clinical study of people living with SPMS, showing Mayzent significantly reduced the risk of disease progression, including impact on physical disability.
Novartis Pharmaceuticals Canada is pleased to announce that Health Canada has approved Mayzent (siponimod) for the treatment of adults with 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.
SPMS follows a relapsing-remitting (RRMS) course of multiple sclerosis (MS) and is characterized by progressive worsening with fewer, or no relapses, and nerve damage or loss. SPMS is defined as active when individuals experience relapses or there is evidence of new MRI activity.