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Investing.com -- Travere Therapeutics Inc (NASDAQ:TVTX) stock surged 8.8% after the U.S. Food and Drug Administration (FDA) approved updated monitoring requirements for its kidney disease treatment FILSPARI.
The regulatory agency reduced the frequency of liver function monitoring from monthly to every three months for patients taking FILSPARI, the company’s Dual Endothelin Angiotensin Receptor Antagonist approved for IgA nephropathy (IgAN). Additionally, the FDA removed the embryo-fetal toxicity monitoring requirement from the drug’s Risk Evaluation and Mitigation Strategy (REMS).
"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 reduced monitoring frequency was supported by safety data from post-marketing surveillance and multiple clinical studies, 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 FDA’s decision to remove the embryo-fetal toxicity monitoring followed an analysis of human pregnancy data from endothelin receptor antagonist medicines used over the past two decades.
Travere also noted that a supplemental New Drug Application for FILSPARI in FSGS is currently under FDA review, with a target action date of January 13, 2026. If approved, FILSPARI would become the first approved medicine specifically indicated for FSGS.
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