Travere Therapeutics’ Filspari (sparsentan) won a fresh FDA milestone, becoming the first fully approved therapy for focal segmental glomerulosclerosis (FSGS). The agency expanded the label based on a regulatory package that validated proteinuria as a surrogate endpoint for the disease, giving the company access to a second large market beyond its initial IgA nephropathy approval. The decision follows an approval path that started with accelerated approval and moved to full approval earlier in the company’s kidney franchise. For clinicians and payers, the expanded label adds a dedicated option for children and adults with FSGS who do not have nephrotic syndrome, a narrower population than some analysts expected.
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