> ## 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.

# Travere sNDA for Filspari Full Approval
- URL: https://www.fdaweb.com/travere-snda-for-filspari-full-approval/
- Published: 2023-12-04T12:00:00.000Z
- Updated: 2026-09-14T14:17:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155914

FDA has told Travere Therapeutics that data appear to support a supplemental NDA to convert the company’s accelerated approval to full approval for Filspari (sparsentan) in IgA nephropathy. Travere says it will submit a supplemental NDA in the first quarter of 2024 on the endothelin and angiotensin II receptor antagonist based on the feedback it recently received from FDA in a pre-NDA meeting.

In the meeting, Travere says it discussed its data on sparsentan for treating focal segmental glomerulosclerosis (FSGS). FDA told the company that its Phase 3 DUPLEX Study results alone are not sufficient to support an sNDA submission for this indication. “As a result, the company will be conducting additional analyses of FSGS data with plans to re-engage FDA in 2024,” Travere says.