Embattled Tenapanor Gets FDA Approval Following CRL In Stunning Turnaround

It’s rare, but it turns out a company seeking approval for a new indication can find success in the wake of an FDA Complete Response Letter (CRL) as is the case for Ardelyx’s Xphozah (tenapanor).

The agency had sent Ardelyx a CRL in 2021, an event from which many drugs never regain approval footing, but Ardelyx didn’t give up, and after much pressing and producing more data, the FDA reconsidered, and gave the pill the green light this week.

With the new approval, tenapanor is now the first phosphate absorption inhibitor for adult chronic kidney disease (CKD) patients on dialysis with hyperphosphatemia, a condition that produces high levels of phosphorus and causes excess calcium to be removed from bones.

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