Travere Therapeutics Announces Ongoing FDA Review for FILSPARI® in FSGS, Target Action Date Set for January 2026

Reuters
Sep 10, 2025
Travere <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Announces Ongoing FDA Review for FILSPARI® in FSGS, Target Action Date Set for January 2026

Travere Therapeutics Inc. has announced that the U.S. Food and Drug Administration (FDA) has decided that an advisory committee meeting is no longer necessary for the review of the supplemental New Drug Application (sNDA) for FILSPARI® (sparsentan) in treating focal segmental glomerulosclerosis $(FSGS)$. The sNDA remains under FDA review with a target action date set for January 13, 2026, under the Prescription Drug User Fee Act (PDUFA). If approved, FILSPARI would become the first medication specifically indicated for FSGS, a serious kidney disorder. FILSPARI has already shown promise in clinical studies, demonstrating significant reductions in proteinuria and offering a potential new therapeutic option for patients with this rare disease. Travere Therapeutics is preparing for a potential commercial launch in January.

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