> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Janssen NDA Filed for MS Drug
- URL: https://www.fdaweb.com/janssen-nda-filed-for-ms-drug/
- Published: 2020-03-18T12:00:00.000Z
- Updated: 2026-09-14T16:07:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146363

Janssen Pharmaceutical has submitted an NDA for ponesimod for treating adult patients with relapsing multiple sclerosis (MS). The selective sphingosine-1-phosphate receptor 1 (S1P1) modulator inhibits S1P protein activity, which is believed to reduce the number of circulating lymphocytes that can cross the blood-brain barrier, the company says. “In patients with MS, the movement of immune cells into the brain damages myelin, the protective sheath that insulates nerve cells,” it explains. “Damage to myelin slows or halts nerve conduction, producing the neurologic signs and symptoms of MS.”

The submission is based on data from the head-to-head OPTIMUM Phase 3 study, which showed superior efficacy of ponesimod 20 mg on the primary endpoint of reduced annualized relapse rate (ARR), as well as most secondary endpoints, compared to Aubagio (teriflunomide) 14 mg in adults with relapsing MS. “At week 108, a highly statistically significant reduction of 30.5% on ARR was observed with ponesimod when compared to Aubagio,” Janssen says. “Additionally, a statistically significant reduction of fatigue symptoms and a 56 percent reduction on combined unique active lesions (CUALs) in the brain were observed with ponesimod compared to Aubagio.”