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Travere Therapeutics Announces FDA Acceptance of sNDA for FILSPARI® (sparsentan) in FSGS
PDUFA target action date of January 13, 2026 If approved, FILSPARI would be the first and only FDA-approved treatment for FSGS, a rare kidney condition and a
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"\nPDUFA target action date of January 13, 2026\n\nIf approved, FILSPARI would be the first and only FDA-approved treatment for FSGS, a rare kidney condition and a leading cause of kidney failure\n\n SAN DIEGO--(BUSINESS WIRE)--\nTravere Therapeutics, Inc. (NASDAQ: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for traditional approval of FILSPARI (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026, and has indicated that it is currently planning to hold an advisory committee meeting to discuss the application.\n\n“Today marks an important milestone in our mission to transform care for patients with rare kidney disease. We are one step closer to potentially delivering the first approved treatment for people living with FSGS — a leading cause of kidney failure and devastating condition that urgently needs new treatment options,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. “With this progress, we continue our commitment to the FSGS community who has been waiting so long for an effective medicine. We look forward to the upcoming review process.”\n\nFILSPARI is the only non-immunosuppressive, oral medication that directly targets podocyte injury by optimally 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.\n\nThe sNDA 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. 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 comparable to maximally dosed irbesartan and consistent across all clinical trials conducted to date. The results from these studies are in alignment with the recent findings of the PARASOL workgroup that support the import...