Travere Therapeutics Announces FDA Drops Advisory Committee For FILSPARI sNDA In FSGS; PDUFA Target Date Set For January 13, 2026

Travere Therapeutics, Inc., (NASDAQ:TVTX) today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that following further review of the supplemental New Drug Application (sNDA) for FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (FSGS), an advisory committee is no longer needed. The sNDA remains under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026.

If approved, FILSPARI would be the first medication indicated for FSGS, a rare and serious kidney disorder driven by proteinuria that leads to progressive kidney function loss and kidney failure. FILSPARI is an oral, non-immunosuppressive potential therapy that targets podocyte injury, a key driver of FSGS progression.

The sNDA is supported by two of the largest and most rigorous head-to-head interventional studies conducted to date in FSGS, the Phase 3 DUPLEX Study and the Phase 2 DUET Study. In these studies, FILSPARI demonstrated rapid, superior and sustained reductions in proteinuria when compared with maximum labeled dose irbesartan across adult and pediatric patients. As published in the New England Journal of Medicine, DUPLEX showed statistically significant and clinically meaningful proteinuria remission at 36 weeks that was durable through 2 years. Patients who achieved partial or complete proteinuria remission in the DUPLEX Study, irrespective of the treatment arm, had a 67% to 77% lower risk of kidney failure, respectively, with the treatment effect of FILSPARI strengthened at more stringent thresholds down to complete remission. The results from these studies are in alignment with the findings of the independent PARASOL workgroup that support the importance of proteinuria in FSGS.

FILSPARI was well-tolerated in the studies with a safety profile consistent across trials and comparable to irbesartan. FILSPARI is fully approved by the FDA and EMA to slow kidney function decline in adults with IgA nephropathy.