U.S. FDA grants appeal for Ardelyx's kidney disease drug

Waltham: The U.S. Food and Drug Administration has granted Ardelyx Inc's appeal for the agency to review its experimental kidney disease drug again, a year after declining to approve it, the company said on Thursday.

The news sent Ardelyx's shares up nearly 15 per cent in premarket 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 U.S. 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 targeting the pathway that absorbs it.

The drug, sold under brand name Ibsrela, has already been approved in the United States and Canada as a treatment for irritable bowel syndrome.

In 2015, Ardelyx bought back rights to the drug from AstraZeneca Plc for $25 million, and developed it alone following troubles with the drug's initial trials.