The FDA has granted full approval to FILSPARI (sparsentan) by Travere Therapeutics for adults with primary IgA nephropathy (IgAN) at risk of disease progression, converting from accelerated approval received in February 2023.16
Full approval is based on the Phase 3 PROTECT Study results, showing FILSPARI provided superior long-term kidney function preservation over two years compared to irbesartan.16
The approval expands access for IgAN patients, with data demonstrating durable benefits on proteinuria reduction and kidney function.1
IgAN is a rare kidney disorder; FILSPARI is now the first drug with full FDA approval specifically for slowing kidney function decline in this condition.67
Sources:
1. https://ir.travere.com/news-releases/news-release-details/travere-therapeutics-announces-full-fda-approval-filsparir/
6. https://www.americanpharmaceuticalreview.com/1315-News/614862-FDA-Approves-Travere-Therapeutics-FILSPARI-for-Kidney-Disease/
7. https://www.docwirenews.com/post/sparsentan-receives-full-fda-approval-for-treatment-of-igan