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# Janssen’s Ponvory Approved for Multiple Sclerosis
- URL: https://www.fdaweb.com/janssens-ponvory-approved-for-multiple-sclerosis/
- Published: 2021-03-19T12:00:00.000Z
- Updated: 2026-09-14T16:51:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148921

FDA has approved a Janssen NDA for Ponvory (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 modulator for treating adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The approval was based on data from a two-year, head-to-head Phase 3 clinical trial in which Ponvory 20 mg demonstrated superior efficacy in significantly reducing annual relapses by 30.5% compared to Sanofi’s teriflunomide (Aubagio) 14 mg in patients with relapsing MS, according to the company. Data showed that 71% of Ponvory patients had no confirmed relapses, compared to 61% in the teriflunomide group. “Ponvory was also superior to teriflunomide in reducing the number of new gadolinium-enhancing (GdE) T1 lesions and the number of new or enlarging T2 lesions by 59% and 56%, respectively,” it says. The lesions are recognized as traditional measures of MS pathology that can provide insights into disease activity and disease burden.