Shares of Travere Therapeutics Inc (NASDAQ:TVTX) jumped 8.8% after the U.S. Food and Drug Administration approved revised monitoring guidelines for its kidney disease therapy FILSPARI.
The FDA has reduced the required liver function checks for patients on FILSPARI from monthly to once every three months. Additionally, the agency eliminated the embryo-fetal toxicity monitoring requirement from the drug’s Risk Evaluation and Mitigation Strategy (REMS). FILSPARI is a Dual Endothelin Angiotensin Receptor Antagonist approved for treating IgA nephropathy (IgAN).
“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,” said Jula Inrig, M.D., Chief Medical Officer of Travere Therapeutics.
The FDA’s decision is backed by post-marketing safety data and results from multiple clinical trials, including the Phase 3 PROTECT Study in IgAN, the Phase 3 DUPLEX Study, and the Phase 2 DUET Study in focal segmental glomerulosclerosis (FSGS). The removal of embryo-fetal toxicity monitoring followed a review of human pregnancy data from endothelin receptor antagonist medications over the past 20 years.
Travere also noted that a supplemental New Drug Application for FILSPARI in FSGS is currently under FDA review, with a target decision date of January 13, 2026. If approved, FILSPARI would become the first treatment specifically indicated for FSGS.
Travere Therapeutics stock price
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