FDA extends FILSPARI FSGS sNDA PDUFA to April 13, 2026; cites Major Amendment

Travere Therapeutics, Inc.

FDA extended PDUFA target action date to April 13, 2026, after determining supplemental NDA responses constitute a Major Amendment.
No safety or manufacturing concerns raised; FDA requested additional characterization of FILSPARI's clinical benefit in FSGS.
If approved, FILSPARI would be the first FDA-approved pharmacologic therapy for focal segmental glomerulosclerosis (FSGS).
Phase 3 DUPLEX study missed primary eGFR slope endpoint but showed proteinuria reduction and lower end-stage kidney disease rate vs irbesartan.

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