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Travere Therapeutics Announces U.S. FDA Approves REMS Modification for FILSPARI® (sparsentan) in IgA Nephropathy
FDA simplifies liver monitoring schedule from monthly to every three months for the duration of treatment and removes embryo-fetal toxicity REMS monitoring
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"\nFDA simplifies liver monitoring schedule from monthly to every three months for the duration of treatment and removes embryo-fetal toxicity REMS monitoring\n\n\n SAN DIEGO--(BUSINESS WIRE)--\nTravere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has approved updated Risk Evaluation and Mitigation Strategy (REMS) labeling for FILSPARI® (sparsentan), the only Dual Endothelin Angiotensin Receptor Antagonist for the treatment of IgA nephropathy (IgAN). The update reduces the frequency of liver function monitoring to every three months from the onset of treatment with FILSPARI and removes the embryo-fetal toxicity (EFT) monitoring requirement from the REMS.\n\n\n“FILSPARI is becoming a foundational treatment for people living with IgA nephropathy, giving patients and their families hope for slowing the progression of their disease,” said Jula Inrig, M.D., chief medical officer of Travere Therapeutics. “Today’s approval of streamlined monitoring requirements reflects the strong safety profile of FILSPARI established to date across clinical and real-world use, simplifying access for patients.”\n\n\nThe reduction of FILSPARI liver monitoring REMS from monthly to every three months from the onset of treatment was supported by safety data from post-marketing surveillance as well as the Phase 3 PROTECT Study in IgAN, the Phase 3 DUPLEX Study, and the Phase 2 DUET Study in focal segmental glomerulosclerosis (FSGS).\n\n\nThe FDA determined that the REMS requirement for EFT for FILSPARI was no longer necessary following an analysis of human pregnancy data compiled from the use of ERA medicines from the last two decades.1\n\n\nA supplemental New Drug Application (sNDA) for FILSPARI in FSGS is currently under review with the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026. If approved, FILSPARI would be the first and only approved medicine indicated for FSGS.\n\n\nAbout IgA Nephropathy\n\n\nIgA nephropathy (IgAN), also called Berger's disease, is a rare progressive kidney disease characterized by the buildup of immunoglobulin A (IgA), a protein that helps the body fight infections in the kidneys. The deposits of IgA cause a breakdown of the normal filtering mechanisms in the kidney, leading to blood in the urine (hematuria), protein in the urine (p...