Business
Ligand Partner Travere Therapeutics Receives Full FDA Approval for FILSPARI® (sparsentan), the Only Non-Immunosuppressive Treatment that Significantly Slows Kidney Function Decline in IgA Nephropathy
FDA approves expanded indication making FILSPARI available to patients with IgA nephropathy (IgAN) at risk of progression; updated label includes data
About this update from Ligand Pharmaceuticals Incorporated
[{"type":"text","content":"\nFDA approves expanded indication making FILSPARI available to patients with IgA nephropathy (IgAN) at risk of progression; updated label includes data showing long-term durable benefit on proteinuria and kidney function preservation that accrued over two years\n\n\nConversion to full approval based on results from the PROTECT Study, where FILSPARI delivered superior long-term kidney function preservation compared to the active comparator irbesartan in the only Phase 3 head-to-head trial conducted in IgAN\n\n\nAs an oral, non-immunosuppressive and dual acting, once-daily medicine with superior long-term results vs. irbesartan, FILSPARI has the potential to become foundational care in IgAN\n\n\nLigand is entitled to a 9% royalty on worldwide net sales of FILSPARI\n\n\n JUPITER, Fla.--(BUSINESS WIRE)--\nLigand Pharmaceuticals Incorporated (Nasdaq: LGND) today announced that its partner Travere Therapeutics, Inc. (Nasdaq: TVTX) has received full approval from the U.S. Food and Drug Administration (FDA) for FILSPARI® (sparsentan) to slow kidney function decline in adults with primary IgAN who are at risk of disease progression. Ligand is entitled to milestone payments and a 9% royalty on worldwide net sales of FILSPARI.\n\n\nFILSPARI was granted accelerated approval in February 2023 based on the surrogate marker of proteinuria. Full approval is based on positive long-term confirmatory results from the PROTECT Study demonstrating that FILSPARI significantly slowed kidney function decline over two years compared to irbesartan.\n\n\n“This announcement is a momentous milestone for Travere and a positive development for people living with this rare kidney disease,” said Todd Davis, CEO of Ligand. “We are encouraged by Travere’s progress to drive adoption of FILSPARI in the U.S. and look forward to the European launch over the coming months. FILSPARI is a core part of Ligand’s commercial-stage royalty portfolio, and we believe this treatment will be a significant driver of revenue for us over the next several years.”\n\n\nFILSPARI is the only oral, once-daily, non-immunosuppressive medication that directly targets glomerular injury in the kidney by blocking two critical pathways of IgAN disease progression (endothelin-1 and angiotensin II).\n\n\nThe two-year efficacy data contained in the FDA-approved label is a modified intention to tre...