The FDA has extended its review of the supplemental New Drug Application (sNDA) for the Travere Therapeutics drug Filspari (sparsentan) in focal segmental glomerulosclerosis (FSGS), a rare disorder that leads to progressive kidney function loss and kidney failure due to proteinuria.
For the drug to receive approval for FSGS, Travere needs to further characterize the clinical benefit of Filspari, which the FDA has determined constitutes a major amendment to the sNDA. Travere continues to prepare for its commercial launch, anticipating approval after the new PDUFA target action date, which is set for April 13, 2026.
Filspari is an oral, non-immunosuppressive potential therapy that targets podocyte injury to prevent progressive FSGS. If the drug does gain approval, it will become the first medication to be indicated for FSGS.
The FDA granted the drug accelerated approval in February 2023 based on the surrogate marker of proteinuria in adults with primary IgAN — another kidney disorder — who are at risk of disease progression. It was granted full appproval in September 2024 to slow kidney function decline in IgAN.