Travere Therapeutics submits sNDA for FILSPARI for IgAN

Travere Therapeutics announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration for conversion of the existing U.S. accelerated approval of FILSPARI in IgA nephropathy to full approval. In February 2023, the FDA granted accelerated approval to FILSPARI as the first and only non-immunosuppressive treatment targeting glomerular injury in the kidney to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression. The sNDA is based on 2-year confirmatory results from the Phase 3 PROTECT Study, the only head-to-head study in IgAN versus an active comparator. FILSPARI is a once-daily, oral medication that directly targets glomerular injury in the kidney by blocking two critical pathways of IgAN disease progression. FILSPARI is also the first and only non-immunosuppressive therapy approved for the treatment of this rare kidney disease. The sNDA submission is supported by results from the Phase 3 PROTECT Study that showed that FILSPARI demonstrated long-term kidney function preservation and achieved a significant reduction in proteinuria and a clinically meaningful difference in eGFR slope versus an active comparator. The FDA has 60 days from the receipt of the application to determine whether to accept it for review. The Company expects to receive notice regarding the acceptance for review of the sNDA submission as well as the timeline for sNDA review from the FDA in the second quarter of 2024.