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.