STAT+: Travere kidney drug narrowly fails confirmatory trial following FDA approval
Travere called the results “clinically meaningful” and said they would bring them to the Food and Drug Administration.
Travere Therapeutics said Thursday that a study meant to confirm the benefit of its newly approved drug for a rare kidney disorder narrowly failed.
In the trial, 404 patients with the disorder, IgA nephropathy, were randomized to receive either Travere’s daily pill, Filspari, or irbesartan, a decades-old blood pressure drug often used to help manage the disease. Early data had showed the drug cut protein levels in the urine, a biomarker of kidney function, by half after nine months. That convinced regulators to give Filspari accelerated approval in February, pending full results using a more direct measure of kidney function.
The new data, after 24 months, showed that patients who received Filspari declined less quickly than those in the control group. But the results just missed statistical significance, with a P value of 0.058.
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