Siponimod receives FDA approval for SPMS


Siponimod (Mayzent), a second-generation sphingosine-1-phosphate (S1P) receptor modulator, has received approval by the U.S. Food and Drug Administration for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome (CIS), relapsing-remitting MS and active secondary-progressive MS (SPMS).

The estimated prevalence of SPMS in the U.S. is 37.1 per 100,000 population (Khurana et al. AAN 2018; abstract P2.380), or approximately 122,000 patients. Only two prior therapies have received approval for SPMS: mitoxantrone, which is infrequently used due to cardiotoxicity; and interferon-beta-1b (in Canada), which is considered to be ineffective in slowing worsening disability (La Mantia et al. Cochrane Database Syst Rev 2012;1:CD005181).

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