FDA Removes Sparsentan (Filspari) Advisory Committee Meeting for FSGS sNDA

Travere Therapeutics has announced that the US Food and Drug Administration (FDA) has informed the Company that following further review of the supplemental New Drug Application (sNDA) for sparsentan (Filspari) in focal segmental glomerulosclerosis (FSGS), an advisory committee is no longer needed.1

According to a September 10, 2025, press release from Travere, 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, sparsentan would be the first medication indicated for FSGS.1

“FSGS is a leading cause of kidney failure, and for too long patients have been waiting for approved therapies for this rare and devastating disease,” Eric Dube, PhD, president and chief executive officer of Travere Therapeutics, said in a press release.1 “We are pleased with the progress of the sNDA to date and look forward to further supporting the FDA’s review of our application for [sparsentan] in FSGS. In parallel, we are continuing our preparations for a successful commercial launch in January, if approved.”

Sparsentan is a non-immunosuppressive, oral medication that directly targets podocyte injury by selectively blocking the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R). Its initial approval came in 2023 in the form of accelerated approval for the reduction of proteinuria in IgA nephropathy, with this expanded to a full approval in September 2024—making the once-daily, oral medication the first non-immunosuppressive treatment for preventing the function of kidney decline in IgA nephropathy.1,2

At the time of the sNDA acceptance for its use in FSGS, the FDA indicated plans to hold an advisory committee meeting to discuss the application.1

The sNDA for its use in FSGS is supported by findings from the phase 3 DUPLEX Study and the Phase 2 DUET Study, two of the largest head-to-head interventional studies conducted to date in adult and pediatric patients with FSGS. In these studies, sparsentan demonstrated rapid, superior and sustained reductions in proteinuria when compared with maximum labeled dose irbesartan across adult and pediatric patients.1,2

The phase 3 DUPLEX study is the largest interventional study to date in FSGS, and the only study in FSGS against a maximally dosed active comparator. 2-year results from the study were published in the New England Journal of Medicine and showed clinically meaningful proteinuria remission at 36 weeks that was durable through 2 years.1,2

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 sparsentan strengthened at more stringent thresholds down to complete remission.1

Of note, the results from DUPLEX and DUET are in alignment with the findings of the independent PARASOL workgroup that support the importance of proteinuria in FSGS. The principal finding from PARASOL was that in FSGS, reduction in proteinuria over 24 months is strongly associated with a reduction in the risk of kidney failure, and responder definitions based on thresholds of proteinuria are both biologically plausible and strongly supported by epidemiological data.1,2

References

1. Travere Therapeutics. Travere Therapeutics Provides Update on FDA Advisory Committee Meeting for FILSPARI® (sparsentan) in FSGS. September 10, 2025. Accessed September 10, 2025. https://ir.travere.com/press-releases/news-details/2025/Travere-Therapeutics-Provides-Update-on-FDA-Advisory-Committee-Meeting-for-FILSPARI-sparsentan-in-FSGS/default.aspx

2. Brooks A. FDA Accepts Sparsentan (Filspari) sNDA for Focal Segmental Glomerulosclerosis. HCPLive. May 15, 2025. Accessed September 10, 2025. https://www.hcplive.com/view/fda-accepts-sparsentan-filspari-snda-for-focal-segmental-glomerulosclerosis