Travere Therapeutics Announces FDA Update on Filspari for Focal Segmental Glomerulosclerosis

Strategic Insights -

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

Key Takeaways:

  • The FDA has informed Travere Therapeutics that an advisory committee is no longer needed for the sNDA of Filspari for FSGS, a rare and serious kidney disorder.
  • The sNDA remains under review by the FDA with a PDUFA target action date of January 13, 2026.
  • If approved, Filspari would be the first medication indicated for FSGS, which is driven by proteinuria leading to progressive kidney function loss and kidney failure.
  • Filspari is an oral, non-immunosuppressive potential therapy targeting 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.
  • Patients who achieved partial or complete proteinuria remission in the DUPLEX Study 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.
  • Filspari was well-tolerated in the studies, with a safety profile consistent across trials and comparable to irbesartan.

Statistics:

  • The Phase 3 DUPLEX Study involved over 300 patients with FSGS and demonstrated rapid and sustained reductions in proteinuria.
  • The Phase 2 DUET Study showed a greater than two-fold reduction in proteinuria compared to irbesartan.
  • The results from the DUPLEX and DUET Studies align with the findings of the independent PARASOL workgroup supporting the importance of proteinuria in FSGS.

Sources:

  • United States Securities and Exchange Commission (SEC) Form 8-K filed by Travere Therapeutics, Inc. on September 10, 2025.
  • The New England Journal of Medicine publication on the DUPLEX Study.