Travere Therapeutics announces FDA accelerated approval of Filspari

Travere Therapeutics announced that the FDA has granted accelerated approval to Filspari to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a urine protein-to-creatinine ratio greater than or equal to1.5 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 in the fourth quarter of 2023 and are intended to support traditional approval of Filspari. The company expects Filspari to be available beginning the week of February 27, and will be providing a comprehensive patient support program throughout the patient’s treatment journey.