Ardelyx Inc (ARDX)

[Cosa]

They didn't see the benefit of using the drug.

The FDA agreed that "the submitted data provide substantial evidence that tenapanor is effective in reducing serum phosphorus in CKD patients on dialysis," according to Ardelyx, but said the treatment effect is "small and of unclear clinical significance."

With that being said they know it works "the submitted data provide substantial evidence that tenapanor is effective in reducing serum phosphorus in CKD patients on dialysis,"

The adcom late last year with testimony from patients and doctors help them understand the benefits. It was voted in favor of approval 9-4 as mono and 10-2 as combo.