Travere Therapeutics to present abstracts at World Congress of Nephrology and American Nephrology Nurses Association on Rare Kidney Disease
Travere Submits sNDA to the FDA Seeking Full Approval of FILSPARI
Travere drug for rare kidney condition recommended for EU approval
Six months after Travere Therapeutics’ Filspari won an accelerated nod to treat patients with a rare kidney disease, the first-of-its-kind drug narrowly failed its confirmatory trial.
FILSPARI® (sparsentan) achieved a clinically meaningful difference vs. irbesartan in eGFR total slope (1.0 mL/min/1.73m2 per year) [p= 0.058] and eGFR chronic slope (1.1 mL/min/1.73m2 per year)...
Travere Therapeutics’ kidney disease strategy has hit a snag. A pivotal phase 3 trial of sparsentan missed its primary endpoint, but the biotech is undeterred, outlining plans to talk to the FDA about a path to market based on other aspects of the data set.
ST. GALLEN, Switzerland, May 2, 2023 /PRNewswire/ -- CSL Vifor today announced topline primary efficacy results from the pivotal Phase 3 DUPLEX Study of sparsentan, a Dual Endothelin Angiotensin Receptor Antagonist (DEARA), in focal segmental glomerulosclerosis (FSGS) from its partner Travere Therapeutics. At the end of the 108-week double-blind period, sparsentan was observed to have a 0.3 mL/min/1.73m2 per year (95% CI: -1.74, 2.41) favorable difference on eGFR total slope and a 0.9 mL/min/1.73m2 per year (95% CI: -1.27, 3.04) favorable difference on eGFR chronic slope compared to the active control irbesartan, which was not statistically significant. After 108 weeks of treatment, sparsentan achieved a mean reduction in proteinuria from baseline of 50%, compared to 32% for irbesartan. Results from the two-year analysis demonstrated that sparsentan was well-tolerated and has shown a comparable safety profile to irbesartan.
SAN DIEGO, April 01, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced publication in The Lancet of the interim analysis of efficacy and safety data from the ongoing pivotal, Phase 3 PROTECT Study evaluating FILSPARI™ (sparsentan) in adults with IgA nephropathy (IgAN). The data are simultaneously being presented in a late-breaking trials session at the World Congress of Nephrology 2023, in Bangkok, Thailand.
Years after cutting ties to its disgraced founder, Martin Shkreli, and after navigating a short regulatory hiccup, Travere Therapeutics has won an FDA approval for a first-of-its-kind drug for a rare kidney disease.