The U.S. Food and Drug Administration (FDA) on Wednesday approved updated Risk Evaluation and Mitigation Strategy (REMS) labeling for Travere Therapeutics, Inc.’s (NASDAQ:TVTX) Filspari (sparsentan), the only Dual Endothelin Angiotensin Receptor Antagonist for IgA nephropathy (IgAN).
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The update reduces the frequency of liver function monitoring to every three months from the onset of treatment with Filspari. It removes the embryo-fetal toxicity (EFT) 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 (FSGS).
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.
A supplemental New Drug Application for Filspari in FSGS is currently under review with the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026.
If approved, Filspari would be the first and only approved medicine indicated for FSGS.
On Wednesday, Vor Bio Inc. (NASDAQ:VOR) announced that its collaborator, RemeGen Co., Ltd., achieved the primary endpoint in Stage A of a Phase 3 clinical study in China evaluating telitacicept in adults with IgAN.
In Stage A of the Phase 3 study, telitacicept achieved the primary endpoint of reducing proteinuria, demonstrating a 55% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) at 39 weeks compared with placebo.
In April, the U.S. Food and Drug Administration (FDA) on Wednesday granted accelerated approval for Novartis AG's (NYSE:NVS) Vanrafia (atrasentan) to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression.
Vanrafia was granted accelerated approval based on a prespecified interim analysis of the Phase 3 ALIGN study measuring the reduction of proteinuria at 36 weeks compared to placebo.
TVTX Price Action: Travere Therapeutics stock is up 7.11% at $18.68 at the last check on Thursday
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