The United States Food and Drug Administration (USFDA) has granted an appeal for Ardelyx’s experimental kidney disease drug after the health regulator delayed its decision earlier this month, the company said last week.
The news sent Ardelyx’s shares up nearly 15 per cent in pre-market trade, with the company saying it now plans to file the marketing application for the drug, tenapanor, in the first half of 2023.
The health regulator had delayed its decision on the appeal earlier this month, after calling a meeting of its advisory committee in November.
The advisers to the FDA last month voted for approval of the drug both as a single therapy, and along with existing treatments, for controlling high phosphate levels in the blood of patients on dialysis.
Last year, the US health regulator had declined approval for the drug, citing efficacy concerns, but had to reconsider and call an advisory panel meeting following the company’s appeal.
Tenapanor is an oral drug that reduces the level of phosphate in the body by targetting the pathway that absorbs it.
The drug, sold under brand name Ibsrela, has already been approved in the US and Canada as a treatment for irritable bowel syndrome.
In 2015, Ardelyx bought back rights to the drug from AstraZeneca for $25 million, and developed it alone following troubles with the drug’s initial trials.
Edits by EP News Bureau
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