Travere Therapeutics Gains FDA Approval for REMS Modification of FILSPARI® in IgA Nephropathy, FSGS Review Ongoing
Reuters
Aug 28
Travere Therapeutics Gains FDA Approval for REMS Modification of FILSPARI® in IgA Nephropathy, FSGS Review Ongoing
Travere Therapeutics Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved a modification to the Risk Evaluation and Mitigation Strategy (REMS) for FILSPARI® (sparsentan), a treatment for IgA nephropathy. The updated REMS reduces the frequency of liver function monitoring to every three months and removes the embryo-fetal toxicity monitoring requirement, reflecting the strong safety profile of FILSPARI. Additionally, a supplemental New Drug Application (sNDA) for FILSPARI in the treatment of focal segmental glomerulosclerosis $(FSGS)$ is under review by the FDA, with a target action date of January 13, 2026. If approved, FILSPARI would become the first and only approved medication for FSGS.
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