Ligand Pharmaceuticals Incorporated announced that its partner Travere Therapeutics, Inc. has received accelerated approval from the U.S. Food and Drug Administration for FILSPARI to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a urine protein-to-creatinine ratio ≥1.5 g/g.
This 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.
FILSPARI, a once-daily oral medication, is designed to selectively target two critical pathways in the disease progression of IgAN 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.
“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,” said Todd Davis, CEO of Ligand Pharmaceuticals. “Our partnership with Travere has been a remarkable journey, and we are proud to have played a part in bringing this innovative treatment to market. Congratulations to the entire team at Travere on this accomplishment.”
Under Ligand’s license agreement with Travere for sparsentan, Ligand is entitled to receive a net $15.3 million milestone on this FDA approval, other potential milestone payments and net royalties of 9% on future global net product sales of sparsentan.
SOURCE: Businesswire