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# Travere’s Filspari Converted to Full Approval
- URL: https://www.fdaweb.com/traveres-filspari-converted-to-full-approval/
- Published: 2024-09-06T12:00:00.000Z
- Updated: 2026-09-14T14:40:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157727

FDA has granted Travere Therapeutics full approval for Filspari (sparsentan) for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. The therapy received accelerated approval 2/23 based on the surrogate marker of proteinuria. Full approval, the company says, is based on positive long-term confirmatory results from the PROTECT Study.

Travere says the endothelin and angiotensin II receptor antagonist directly targets glomerular injury in the kidney by blocking two critical pathways of IgAN disease progression (endothelin-1 and angiotensin II). “Results from the PROTECT Study showed that FILSPARI was well tolerated with a clearly defined safety profile that has been consistent across all clinical trials conducted to date,” it says. “Following engagement with the FDA, the company expects to submit an sNDA for a potential modification to the liver-monitoring REMS.”