Travere Therapeutics’ filspari granted FDA approval for REMS labeling

Travere Therapeutics (TVTX) announced that the FDA has approved updated Risk Evaluation and Mitigation Strategy, or REMS, labeling for filspari – sparsentan -, the only Dual Endothelin Angiotensin Receptor Antagonist for the treatment of IgA nephropathy. The update reduces the frequency of liver function monitoring to every three months from the onset of treatment with filspari and removes the embryo-fetal toxicity monitoring requirement from the REMS. The reduction of FILSPARI liver monitoring REMS from monthly to every three months from the onset of treatment was supported by safety data from post-marketing surveillance as well as the Phase 3 PROTECT Study in IgAN, the Phase 3 DUPLEX Study, and the Phase 2 DUET Study in focal segmental glomerulosclerosis. The FDA determined that the REMS requirement for EFT for filspari was no longer necessary following an analysis of human pregnancy data compiled from the use of ERA medicines from the last two decades. An sNDA for filspari in FSGS is currently under review with the FDA, with a PDUFA target action date of January 13, 2026. If approved, filspari would be the first and only approved medicine indicated for FSGS.