Travere's FILSPARI Approved by FDA for FSGS, First & Only Medicine

Travere Therapeutics announced that the FDA has approved FILSPARI (sparsentan) to reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome. This marks FILSPARI as the first and only FDA-approved medicine for FSGS, expanding its use beyond IgA nephropathy into a second rare kidney disease. The company estimates an addressable U.S. population of over 30,000 individuals with FSGS who do not have nephrotic syndrome. In the Phase 3 DUPLEX Study, FILSPARI demonstrated a statistically significant 46% reduction in proteinuria from baseline to Week 108 in the overall study population, compared to 30% for irbesartan.