Travere Filing sNDA for Filspari Full Approval

Travere Therapeutics says it plans to seek full approval in an sNDA in the first half of 2024 for its accelerated approval drug Filspari (sparsentan), based on confirmatory trial data that “demonstrated long-term kidney function preservation and achieved a clinically meaningful difference in estimated glomerular filtration rate (eGFR) total and chronic slope versus irbesartan.” However, Filspari in the trial narrowly missed statistical significance in eGFR total slope while achieving statistical significance in eGFR chronic slope.

Travere says Filspari is an endothelin and angiotensin II receptor antagonist indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. A preliminary safety review of study data showed that through 110 weeks of treatment the drug was generally well-tolerated and the overall safety profile in the study had been consistent between treatment groups.