Ligand’s Partner Travere Therapeutics Announces FDA Accelerated Approval of FILSPARI™ (sparsentan), the First and Only Non-immunosuppressive Therapy for the Reduction of Proteinuria in IgA Nephropathy

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[{"type":"text","content":"\nFirst single molecule Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved for use in patients with IgA nephropathy (IgAN)\n\nInterim results from the ongoing Phase 3 PROTECT head-to-head trial demonstrated a rapid, sustained and clinically meaningful reduction in proteinuria vs. active control, irbesartan\n\nLigand is entitled to receive a net $15.3 million milestone and net royalties of 9% on future sales\n\n SAN DIEGO--(BUSINESS WIRE)--\nLigand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that its partner Travere Therapeutics, Inc. (Nasdaq: TVTX) has received accelerated approval from the U.S. Food and Drug Administration (FDA) for FILSPARI™ (sparsentan) to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g.\n\nThis indication is granted under accelerated approval based on reduction in proteinuria. It has not been established whether FILSPARI slows kidney function decline in patients with IgAN. The continued approval of FILSPARI may be contingent upon confirmation of a clinical benefit in the ongoing Phase 3 PROTECT Study, which is designed to demonstrate whether FILSPARI slows kidney function decline. Topline results from the two-year confirmatory endpoints in the PROTECT Study are expected by Travere in the fourth quarter of 2023 and are intended to support traditional approval of FILSPARI.\n\nFILSPARI, a once-daily oral medication, is designed to selectively target two critical pathways in the disease progression of IgAN (endothelin-1 and angiotensin II) and is the first and only non-immunosuppressive therapy approved for the treatment of this condition. IgAN is a rare kidney disease and a leading cause of kidney failure due to glomerular disease, affecting up to 150,000 people in the U.S., with approximately 30,000 to 50,000 of such patients estimated to be addressable under the indication approved via accelerated approval. Travere expects FILSPARI to be available beginning the week of February 27, 2023, and has indicated it will be providing a comprehensive patient support program throughout the patient’s treatment journey.\n\n\"We are delighted to see the approval of sparsentan, now FILSPARI, which represents a significant step forward in improving the lives of patients living with IgA nephropathy,” sai...

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