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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.
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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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