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Travere Gets FDA Approval for REMS Modification for Filspari in IgA Nephropathy
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Travere Gets FDA Approval for REMS Modification for Filspari in IgA Nephropathy
Aug 27, 2025 3:11 PM

05:49 PM EDT, 08/27/2025 (MT Newswires) -- Travere Therapeutics ( TVTX ) said late Wednesday the US Food and Drug Administration has approved updated Risk Evaluation and Mitigation Strategy labeling for Filspari to treat IgA nephropathy, a rare progressive kidney disease.

The update cuts the frequency of liver function monitoring to every three months from monthly and removes the embryo-fetal toxicity monitoring requirement from the REMS, Travere said.

The company also said a supplemental new drug application for the drug in focal segmental glomerulosclerosis is under review with the FDA, with a target action date of Jan. 13, 2026.

Shares were up about 4% during after-hours trading.

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