Travere Therapeutics’ sparsentan (Filspari) won FDA approval for focal segmental glomerulosclerosis (FSGS), expanding the label for a drug that had already received accelerated clearance for IgA nephropathy. The approval makes Filspari the first fully FDA-approved therapy for FSGS and creates a second marketed indication for the company. The regulatory package validated proteinuria as a surrogate endpoint for the FSGS setting and includes label specifics for children and adults aged 8 and older who do not have nephrotic syndrome. Analysts and company commentary focused on the commercial potential of pairing FSGS and IgA nephropathy sales as the program matures. Travere said it expects the expanded opportunity to strengthen revenue dynamics as it builds on its earlier approvals, while clinicians gain a new option for a rare but high-burden kidney disorder.
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