Ardelyx Inc. (NASDAQ: ARDX) has announced that the US FDA has issued it with a Complete Response Letter for its New Drug Application for tenapanor for serum phosphorous control in chronic kidney disease adult patients on dialysis.
FDA says tenapanor impact is minimal and unclear
The CRL indicates that the FDA agreed with provided data that it offered adequate evidence on the effectiveness of tenapanor in serum phosphorous reduction in CKD adult patients in dialysis. However, the FDA characterized the treatment effect’s impact as minimal and of indistinct clinical significance. Therefore, for the application to receive approval, the FDA pointed out that the company should carry a more significant and well-controlled study to demonstrate the effect of treatment on serum phosphorous or the clinical outcome effects of hyperphosphatemia in patients with CKD on dialysis. Most importantly, there were no non-clinical, CMC, safety, or biopharmaceutics/clinical pharmacology issues identified in the CRL.
The FDA has indicated that it is will to meet with the company to discuss approval options. Accordingly, Ardelyx plans to request a Type A meeting soon to discuss the CRL and potential avenues ahead of the tenapanor’s approval to regulate serum phosphorus in adult CKD patients on dialysis.
Ardelyx disagrees with FDA CRL
CEO Mike Raab said, “We are saddened by this communication from the FDA and what it means for the patients and the physicians who treat them. We continue to believe tenapanor represents an important, first-in-class treatment option for patients with elevated phosphorus. We do not agree with the FDA’s subjective assessment on the clinical relevance of the treatment effect of tenapanor in our studies which met all clinical endpoints agreed upon by the FDA. In our view, the serum phosphorus lowering data generated with tenapanor in all of our clinical studies is meaningful and clinically significant. We will work with the agency to address the issues raised and, to the extent possible, find an expeditious path forward.”
