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Travere Therapeutics Submits sNDA to FDA for Approval of FILSPARI® (sparsentan) for the Treatment of FSGS
sNDA submission based on results from Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI in FSGS If approved, FILSPARI could become the first and only
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"sNDA submission based on results from Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI in FSGS If approved, FILSPARI could become the first and only FDA-approved treatment for FSGS, a rare kidney condition and a leading cause of kidney failure Additionally, the FDA notified the Company that REMS monitoring for embryo-fetal toxicity is no longer necessary; the Company plans to submit an amendment to the REMS sNDA currently under review for modification of liver monitoring SAN DIEGO, March 17, 2025 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced the Company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking priority review for traditional approval of FILSPARI® (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS). The submission is supported by results 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. “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, Ph.D., president and chief executive officer of Travere Therapeutics. “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.” FILSPARI 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). It is currently approved to slow kidney function decline in adults with IgA nephropathy, a leading cause of kidney failure. The DUPLEX and DUET studies demonstrated that FILSPARI provided rapid, superior and sustained reductions in proteinuria when compared with maximum labeled dose irbesartan, in children and adults with FSGS. In the DUPLEX and DUET studies, FILSPARI was well-tolerated with a safety profile that was consistent across all clinical trials conducted to date. The FDA has 60 days from the receip...