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

Reuters
2025/09/10
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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Travere Therapeutics Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250910301976) on September 10, 2025, and is solely responsible for the information contained therein.

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