Travere Therapeutics to Submit sNDA for FILSPARI® (sparsentan) in FSGS

Core Insights - Travere Therapeutics has completed a Type C meeting with the FDA and plans to submit a supplemental New Drug Application (sNDA) for FILSPARI, targeting focal segmental glomerulosclerosis (FSGS) [1][2] - If approved, FILSPARI could be the first and only approved treatment for FSGS, a rare kidney disorder affecting over 40,000 patients in the U.S. [2][5] - The sNDA submission will rely on data from the Phase 3 DUPLEX and Phase 2 DUET studies, which have shown promising results in reducing proteinuria [1][6][7] Company Updates - The sNDA submission is expected around the end of the first quarter of 2025 [1] - The CEO of Travere Therapeutics expressed optimism about the sNDA submission and highlighted the urgent need for treatment options for FSGS [2] - A conference call and webcast will be held to discuss these updates, scheduled for February 11, 2025, at 8:30 a.m. ET [3][4] Study Insights - The Phase 3 DUPLEX study is noted as the largest interventional study in FSGS, achieving significant results in reducing proteinuria [6][7] - The Phase 2 DUET study demonstrated a greater than two-fold reduction in proteinuria compared to irbesartan, indicating the efficacy of FILSPARI [7] - Both studies support the importance of proteinuria reduction as a key endpoint in FSGS treatment, aligning with findings from the PARASOL workgroup [2][8] Disease Context - FSGS is characterized by progressive kidney scarring and is a leading cause of kidney failure, with no currently approved pharmacologic treatments [5] - The disorder affects both adults and children, highlighting the need for effective therapies [5]