Travere Therapeutics Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for FILSPARI® (sparsentan) for the treatment of focal segmental glomerulosclerosis $(FSGS)$, a rare kidney disease. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026, for the potential approval. If approved, FILSPARI would become the first FDA-approved treatment specifically for FSGS. This application is supported by positive results from the Phase 3 DUPLEX Study and the Phase 2 DUET Study, which demonstrated the drug's efficacy in reducing proteinuria in both children and adults with FSGS. The FDA has also indicated plans to hold an advisory committee meeting to discuss the application.
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