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# Travere Therapeutics NDA Accepted for Sparsentan
- URL: https://www.fdaweb.com/travere-therapeutics-nda-accepted-for-sparsentan/
- Published: 2022-05-16T12:00:00.000Z
- Updated: 2026-09-14T17:44:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151816

FDA has accepted for priority review a Travere Therapeutics NDA for sparsentan and its use in treating IgA nephropathy (IgAN). The company says it is seeking accelerated approval, and, if approved, sparsentan would be the first FDA-approved non-immunosuppressive treatment option for IgA nephropathy. The agency has set an 11/17 user fee review action target date.

The submission is based on data from the ongoing Phase 3 PROTECT Study, which is evaluating 404 patients with persistent proteinuria. Travere says the study met its pre-specified interim primary efficacy endpoint measuring change in proteinuria compared to the active control, irbesartan. “After 36 weeks of treatment,” the company says, “patients receiving sparsentan achieved a mean reduction in proteinuria from baseline of 49.8%, compared to a mean reduction in proteinuria from baseline of 15.1% for irbesartan-treated patients (p<0.0001).”

IgAN is also called Berger's disease, a rare kidney disorder characterized by the buildup of immunoglobulin in the kidneys, which causes a breakdown of the normal filtering mechanisms in the kidney that causes blood and protein in the urine, according to the company.