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# Filspari sNDA Accepted for Rare Kidney Disease
- URL: https://www.fdaweb.com/filspari-snda-accepted-for-rare-kidney-disease/
- Published: 2025-05-16T12:00:00.000Z
- Updated: 2026-09-14T15:12:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159199

FDA has accepted for review a Travere Therapeutics supplemental NDA for traditional approval of Filspari (sparsentan) for treating focal segmental glomerulosclerosis (FSGS), a rare and serious kidney disorder. The agency has set a review action target date of 1/13/2026, and told the company that it plans to convene an advisory committee meeting to review the application.

Filspari is a non-immunosuppressive, oral therapy that targets kidney podocyte injury by blocking both the endothelin A receptor and angiotensin II subtype 1 receptor. It is currently approved to slow kidney function decline in patients with immunoglobulin A nephropathy.

The company says the submission is backed by data from the Phase 3 DUPLEX and Phase 2 DUET studies, which demonstrated that Filspari achieved significant and sustained reductions in proteinuria — a key marker of kidney disease progression — compared to standard therapy irbesartan. Although the DUPLEX study did not meet its primary endpoint related to kidney function decline over 108 weeks, it did show significant clinical benefits, including a lower rate of progression to end-stage kidney disease, it says.