Travere Therapeutics Submits sNDA for Sparsentan (Filspari) in FSGS

Travere Therapeutics has announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking priority review for traditional approval of sparsentan (Filspari) for the treatment of focal segmental glomerulosclerosis (FSGS).1

Announced on March 17, 2025, the submission is supported by results from the phase 3 DUPLEX Study and the phase 2 DUET Study, described by Travere as 2 of the largest head-to-head interventional studies conducted to date in adult and pediatric patients with FSGS.1

“There is a profound and urgent need for effective treatment options that can target glomerular injury, reduce proteinuria, and preserve kidney function in FSGS,” said Eric Dube, PhD, president and chief executive officer of Travere Therapeutics.1 “Since its approval in IgA nephropathy, we have seen the positive impact FILSPARI can have on patients living with rare kidney disease. We have great hope to potentially bring FILSPARI as the first approved treatment for patients with FSGS and this sNDA submission is an important next step toward that goal. We look forward to the upcoming review process.”

The company previously announced its intent to submit an sNDA for sparsentan on February 11, 2025, following the completion of a Type C meeting with the FDA.2

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 first 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

In the DUPLEX and DUET studies, sparsentan provided rapid, superior, and sustained reductions in proteinuria when compared with maximum labeled dose irbesartan in children and adults with FSGS. In both studies, sparsentan was well-tolerated with a safety profile that was consistent across all clinical trials conducted to date.1

According to the release from Travere, the FDA has 60 days from the receipt of the application to determine whether to accept it for review. The Company expects to receive notice regarding the acceptance for review of the sNDA submission as well as the timeline for sNDA review from the FDA in Q2 of 2025.1

Additionally, the FDA recently notified the company that the REMS is no longer necessary to ensure the benefits of sparsentan outweigh the risk of embryo-fetal toxicity and to minimize the burden on the healthcare delivery system. Accordingly, Travere detailed plans to submit a REMS modification to remove the need to monitor the risk of embryo-fetal toxicity as an amendment to the REMS sNDA currently under review for potential modification of liver monitoring.1

Of note, the FDA indicated that this amendment is not expected to impact the review timeline and the Company continues to expect a REMS modification PDUFA target action date of August 28, 2025.1

References

1. Travere Therapeutics. Travere Therapeutics Submits sNDA to FDA for Approval of FILSPARI® (sparsentan) for the Treatment of FSGS. March 17, 2025. Accessed March 17, 2025. https://ir.travere.com/news-releases/news-release-details/travere-therapeutics-submits-snda-fda-approval-filsparir

2. Campbell P. Travere Therapeutics Plans FSGS Submission for Sparsentan. HCPLive. February 11, 2025. Accessed March 17, 2025. https://www.hcplive.com/view/travere-therapeutics-plans-fsgs-submission-for-sparsentan