FDA says no advisory committee needed for FILSPARI sNDA in FSGS; PDUFA Jan 13, 2026

Travere Therapeutics, Inc.

FDA informed Travere that an advisory committee is no longer needed for the FILSPARI (sparsentan) sNDA for FSGS.
The sNDA remains under review with a PDUFA target action date of January 13, 2026.
If approved, FILSPARI would be the first medication indicated for FSGS, a rare kidney disorder.
sNDA is supported by Phase 3 DUPLEX and Phase 2 DUET studies showing superior proteinuria reduction vs. irbesartan.
FILSPARI is already fully approved for IgA nephropathy in the US and EU.

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