Travere Therapeutics Inc. released data from a late-stage study of Filspari in IgA nephropathy, a rare kidney disease. In a head-to-head study versus irbesartan, Filspari fell short of producing a statistically significant difference by one measure of kidney function, although patients on the treatment had some of the slowest annual rates of kidney function decline seen in IgA nephropathy clinical trials, Travere said in a release.
Travere Therapeutics Announces Confirmatory Data from the Phase 3 PROTECT Study of FILSPARI Demonstrating Long-Term Kidney Function Preservation in IgA Nephropathy; Narrowly Missing eGFR Total Slope Endpoint versus Active Control, Irbesartan
SAN DIEGO, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced topline two-year confirmatory secondary endpoint results from the Company's pivotal head-to-head Phase 3 PROTECT Study of FILSPARI (sparsentan) in IgA nephropathy (IgAN) versus irbesartan. FILSPARI demonstrated long-term kidney function preservation and achieved a clinically meaningful difference in estimated glomerular filtration rate (eGFR) total and chronic slope versus irbesartan, narrowly missing statistical significance in eGFR total slope while achieving statistical significance in eGFR chronic slope for purposes of regulatory review in the EU. FILSPARI is currently available under accelerated approval in the U.S. The Company will engage with regulators and expects to submit a supplemental New Drug Application (sNDA) in 1H 2024 for full approval in the U.S.
Ligand Pharma (LGND) announces that its partner Travere Therapeutics (TVTX) released topline, two-year confirmatory secondary endpoint results from its pivotal, head-to-head Phase 3 PROTECT Study of FILSPARI in IgA nephropathy versus irbesartan
- FILSPARI demonstrated long-term kidney function preservation and achieved a clinically meaningful difference in estimated glomerular filtration rate total and chronic slope versus irbesartan, narrowly missing statistical significance in eGFR total slope while achieving statistical significance in eGFR chronic slope for purposes of regulatory review in the EU. FILSPARI is currently available under accelerated approval in the U.S. Travere will engage with regulators and expects to submit a supplemental New Drug Application in 1H 2024 for full approval in the U.S.
- Under Ligand's license agreement with Travere for FILSPARI, Ligand is entitled to receive net royalties of 9% on global net product sales of FILSPARI.
