Unicycive Resubmits NDA for Hyperphosphatemia Drug

FDA has accepted for review a Unicycive Therapeutics NDA resubmission for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The submission addresses a June Complete Response Letter (CRL) that cited deficiencies previously identified at a third-party manufacturing vendor. The agency set a user fee review action target date of 3/25/2027.

“This resubmission includes CMC data from a new third-party drug product manufacturing vendor,” the company says. “The new vendor’s facility was last inspected by the FDA in March 2024 and received ‘No Action Indicated’ status. We hope to continue working with the FDA toward potential approval of this important medication to patients with CKD on dialysis who need additional treatment options for managing hyperphosphatemia.”

Unicycive says it has not received word from FDA on whether it will decide to conduct a pre-approval inspection. “Additionally, if the original third-party manufacturing vendor is inspected in the near term and finds that its facility complies with current Good Manufacturing Practice (cGMP), the Company plans to seek FDA alignment on a shorter approval timeline,” it says.

The NDA is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and CMC data, according to the company. FDA did not raise any concerns regarding OLC’s preclinical or clinical data, including safety data, included in the original NDA submission, it adds.

“OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease on dialysis,” Unicycive says.