Ligand Pharmaceuticals Inc. (LGND) announced Tuesday that its partner Travere Therapeutics, Inc. (TVTX) has received approval from the U.S. Food and Drug Administration (FDA) for FILSPARI (sparsentan) to reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome.
FILSPARI is the first and only medicine approved by the FDA for the treatment of FSGS, marking its expansion beyond IgA nephropathy (IgAN) into a second rare kidney disease.
FILSPARI is currently the most commonly prescribed FDA-approved medicine for IgAN and Ligand is entitled to a 9% royalty on worldwide net sales.
In Travere's Phase 3 DUPLEX Study, the largest head-to-head interventional study in FSGS to date, patients treated with FILSPARI in the overall study population experienced a statistically significant 46% reduction in proteinuria from baseline to Week 108 compared to 30% for those treated with maximum labeled dose irbesartan.
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