First FDA-approved therapy for FSGS: FILSPARI wins full approval

The FDA granted full approval for FILSPARI (sparsentan) to reduce proteinuria in adults and children 8+ with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome, making it the first FDA-approved treatment for this rare kidney disease and expanding the U.S. addressable population to over 100,000 patients with FSGS and IgAN. In the Phase 3 DUPLEX trial, FILSPARI achieved a 46% reduction in proteinuria overall (48% in non-nephrotic patients) versus irbesartan, with a safety profile similar to irbesartan; however, hepatotoxicity risk requires REMS and there are important pregnancy contraindications and drug interactions, including avoidance with ARBs/ERAs and certain CYP3A modulators. Travere will host a conference call to discuss the approval.