FDA Issues Complete Response Letter to Unicycive, Delaying Kidney Disease Treatment

Unicycive Therapeutics has encountered a setback in its efforts to bring a new hyperphosphatemia treatment to chronic kidney disease (CKD) patients on dialysis. The U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) to the company, citing manufacturing issues at a third-party vendor.

Manufacturing Concerns Prompt FDA Response

The CRL, which delays the potential approval of Unicycive's oxylanthanum carbonate (OLC) drug product, specifically addresses deficiencies identified during a recent inspection of the third-party manufacturing facility. Importantly, the FDA did not raise any concerns regarding the safety or clinical data of the treatment, nor did it note any technical issues related to the documentation or testing of OLC.

Shalabh Gupta, M.D., CEO of Unicycive, stated, "We remain optimistic about our ability to bring this promising new treatment option to patients with CKD on dialysis who are managing hyperphosphatemia, and we plan to provide an update as soon as we have additional clarity on next steps from the FDA."

Unicycive's Contingency Plan and Next Steps

In response to the setback, Unicycive has revealed that it had already lined up a second manufacturer as a backup to ensure redundancy in its supply chain. This alternative manufacturer reportedly has a long history of successful regulatory inspections and has already produced OLC drug product, potentially expediting the resolution of the issues raised in the CRL.

The company plans to seek a meeting with the FDA to align on the best strategy for a rapid resolution. Gupta emphasized, "With a second manufacturing vendor identified that has produced OLC drug product, we remain optimistic about our ability to bring this promising new treatment option to patients."

OLC: A Novel Approach to Hyperphosphatemia Treatment

OLC is an oral phosphate binder developed using Unicycive's nanoparticle technology. The treatment aims to reduce the number and size of pills required for hyperphosphatemia management, potentially improving patient compliance and outcomes.

Hyperphosphatemia, a condition characterized by elevated phosphate levels in the blood, affects nearly all patients with end-stage renal disease. According to Unicycive, over 450,000 people in the United States require medication to control their phosphate levels annually. The condition, if left untreated, is associated with increased mortality and hospitalization rates among CKD patients on dialysis.

As Unicycive works to address the manufacturing concerns, the pharmaceutical industry watches closely, recognizing the potential impact of OLC on the lives of hundreds of thousands of patients managing this serious complication of kidney disease.