Travere Therapeutics’ Filspari (sparsentan) cleared a key regulatory milestone by becoming the first fully FDA-approved treatment for focal segmental glomerulosclerosis (FSGS). The expanded label adds a second lucrative indication beyond Travere’s earlier IgA nephropathy approvals. The approval gives Travere access to a market viewed as potentially exceeding $1 billion annually, with regulators validating proteinuria as a surrogate endpoint for this patient population. The label also specifies dosing and eligibility criteria that analysts said were likely to shape launch dynamics. The FDA’s decision marks a meaningful recovery after earlier trial setbacks in the same clinical area and provides a clearer path for commercial scaling in a rare kidney disease segment.