Siponimod: A new approved oral drug to treat multiple sclerosis

The U.S. Food and Drug Administration on 26 March 2019 approved Siponimod tablets to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The efficacy of Siponimod was shown in a clinical trial of 1,651 patients that compared Siponimod to placebo in patients with Secondary Progressive Multiple Sclerosis (SPMS) who had evidence of disability progression in the prior two years and no relapses in the three months prior to enrollment. The primary endpoint of the study was the time to three-month confirmed progression in disability. The fraction of patients with confirmed progression of disability was statistically significantly lower in the Siponimod group than in the placebo group. Siponimod also decreased the number of relapses experienced by these patients. In the subgroup of patients with non-active SPMS, the results were not statistically significant.