Travere Gets FDA Approval for REMS Modification for Filspari in IgA Nephropathy

 FDA simplifies liver monitoring schedule from monthly to every three months for the duration of treatment and removes embryo-fetal toxicity REMS monitoring

Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has approved updated Risk Evaluation and Mitigation Strategy (REMS) labeling for FILSPARI® (sparsentan), the only Dual Endothelin Angiotensin Receptor Antagonist for the treatment of IgA nephropathy (IgAN). 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 (EFT) monitoring requirement from the REMS.

https://www.businesswire.com/news/home/20250827211581/en/Travere-Therapeutics-Announces-U.S.-FDA-Approves-REMS-Modification-for-FILSPARI-sparsentan-in-IgA-Nephropathy