Ardelyx’s Tenapanor Hits Another Regulatory Stumbling Block On Label, Post-Marketing Commitments
While not an outright rejection, the Deficiencies Preclude Discussion letter came as a surprise given the expectation of the drug’s approval for hyperphosphatemia in adults with chronic kidney disease on dialysis.
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The company reported positive Phase III data from a second trial testing the first-in-class therapy as monotherapy for managing hyperphosphatemia in patients on dialysis.
Tenapanor approved for IBS-C as Ibsrela, but Ardelyx is still seeking a commercial partner for that indication – and is maintaining focus on same molecule in hyperphosphatemia.
The company plans an intensive review to determine the path forward for SER-287. A similar deep dive led to the successful revival of its C. difficile drug, SER-109, which it plans to submit for approval.