Travere gains FDA approval for Filspari in primary IgAN

The US Food and Drug Administration (FDA) has granted accelerated approval for Travere Therapeutics’ (Nasdaq: TVTX) 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.

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 III PROTECT Study, which is designed to demonstrate whether FILSPARI slows kidney function decline. Top-line results from the two-year confirmatory endpoints in the PROTECT Study are expected in the fourth quarter of 2023 and are intended to support traditional approval of Filspari.

Under Ligand Pharmaceuticals' (Nasdaq: LGND) 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.