The U.S. FDA has granted full approval to Travere Therapeutics’ Filspari to reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome.
Filspari is an oral, non-immunosuppressive potential therapy that targets podocyte injury to prevent progressive FSGS. It is the first and only medicine approved by the FDA for the treatment of FSGS, marking its expansion beyond IgA nephropathy (IgAN) into a second rare kidney disease.
Earlier this year, the FDA extended the review of Travere’s sNDA for FSGS, directing the drugmaker to further characterize the clinical benefit of Filspari.
The FDA initially 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.