Travere Therapeutics Receives FDA Approval for REMS Update on FILSPARI® (sparsentan) in IgA Nephropathy
Thursday, August 28, 2025
Travere Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved modifications to the Risk Evaluation and Mitigation Strategy (REMS) for FILSPARI® (sparsentan), the only dual endothelin angiotensin receptor antagonist approved for the treatment of IgA nephropathy (IgAN).
The revised REMS reduces the frequency of liver function monitoring from monthly checks to once every three months from the start of treatment. In addition, the requirement for embryo-foetal toxicity (EFT) monitoring has been removed.
The decision was based on safety data from post-marketing surveillance, along with findings from the Phase 3 PROTECT trial in IgAN, the Phase 3 DUPLEX trial, and the Phase 2 DUET trial in focal segmental glomerulosclerosis (FSGS). The FDA also concluded that EFT monitoring was no longer necessary after reviewing two decades of human pregnancy data linked to endothelin receptor antagonist (ERA) medicines.
A supplemental New Drug Application (sNDA) for FILSPARI in FSGS is currently under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) target decision date of 13 January 2026. If approved, FILSPARI would be the first approved treatment for FSGS.
Source: businesswire.com
