Travere submits sNDA to FDA seeking priority review for FILSPARI in FSGS

Travere Therapeutics, Inc.

Submitted sNDA on March 17, 2025 seeking priority review for traditional approval of FILSPARI (sparsentan) for FSGS.
Supported by Phase 3 DUPLEX study (interim FPRE endpoint met; primary eGFR slope missed) and Phase 2 DUET study (met primary endpoint).
FDA has 60 days to decide on acceptance; company expects notice in Q2 2025.
If approved, FILSPARI would be first FDA-approved therapy for FSGS, affecting >40,000 US patients.
No currently approved pharmacologic therapies for FSGS.

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