Unicycive Therapeutics, a clinical-stage biotech company based in Los Altos, California, has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for oxylanthanum carbonate (OLC), an oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis.
According to Unicycive, the FDA cited deficiencies identified during a recent current Good Manufacturing Practice (cGMP) inspection of a third-party manufacturing vendor used by its contract development and manufacturing organization. The cited issues were not directly related to OLC. The company also stated that the FDA did not identify concerns with the clinical, preclinical, or safety data submitted as part of the application.
To address the CRL, Unicycive plans to request a Type A meeting with the FDA to clarify next steps and determine the most efficient path forward. The company said it had already established a second qualified manufacturing vendor that has successfully produced OLC drug products. This vendor could be used to support resolution of the chemistry, manufacturing and controls (CMC) issues noted in the letter.
OLC is being evaluated for approval under the FDA’s 505(b)(2) pathway. The NDA submission included results from three clinical trials — two in healthy volunteers and one in dialysis patients — as well as CMC data and preclinical studies, according to the company.