Travere Therapeutics Gains FDA Approval for REMS Modification of FILSPARI® in IgA Nephropathy, FSGS Review Ongoing

Reuters
08/28
Travere <a href="https://laohu8.com/S/LENZ">Therapeutics</a> 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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Travere Therapeutics Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250827211581) on August 27, 2025, and is solely responsible for the information contained therein.

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