The FDA approved Travere Therapeutics’ Filspari (sparsentan) for focal segmental glomerulosclerosis (FSGS), making it the first and only fully FDA-approved treatment in this indication. The approval adds a new market and follows prior accelerated approval milestones across other kidney diseases. Reports indicate the expanded label validates proteinuria as a surrogate endpoint for the FSGS population and includes use restrictions tied to patient eligibility criteria. Analysts have framed the label expansion as meaningful for peak revenue opportunity. Clinically, the decision changes the treatment landscape for FSGS patients who previously lacked a fully approved option, while also reinforcing proteinuria-centric regulatory pathways in nephrology.