Travere Therapeutics just misses on confirmatory study for kidney disease drug, stock plummets
Travere Therapeutics’ kidney disease drug narrowly failed its confirmatory study seven months after it won accelerated approval.
Travere said Thursday it still intends to apply for full approval of Filspari in IgA nephropathy in the first half of next year, meaning the FDA will have to weigh the study results and decide whether to pull the drug.
The key endpoint in the Phase III study was a measure of kidney function known as estimated glomerular filtration rate (eGFR) total slope. The smaller the slope, the slower the decline of kidney function. Patients either received Filspari or irbesartan — a generic blood pressure drug used to treat nephropathy. Over 110 weeks, patients who received Filspari saw a smaller change in their eGFR total slope compared to those in the comparator arm. But the difference between the total slopes of the two groups had a p-value of 0.058, just missing statistical significance.
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