Unicycive says FDA found deficiencies at a third-party manufacturing vendor

Biotechnology company Unicycive Therapeutics announced that the FDA has identified compliance deficiencies at a third-party manufacturing vendor tied to its new drug application for oxylanthanum carbonate (OLC), a phosphate binder candidate for patients with chronic kidney disease on dialysis.

The agency said the issues preclude any label discussions at this time, but a final decision is still expected by the June 28 PDUFA target date, according to the company announcement.

Unicycive said the deficiencies occurred at a subcontractor of its contract development and manufacturing organization and did not involve the drug substance vendor. The company stated it has responded to all FDA requests and is in active discussions with its partners to address the agency’s concerns.

Despite the regulatory hurdle, Unicycive says it remains confident in the potential of OLC, which uses nanoparticle technology to reduce pill burden while maintaining high phosphate-binding potency. The NDA submission was filed via the 505(b)(2) pathway and includes data from three clinical trials and multiple preclinical studies.

Hyperphosphatemia affects nearly all U.S. patients with end-stage renal disease, and current treatments rely on oral phosphate binders to control serum phosphate levels. There are currently more than 450,000 individuals in the U.S. that require medication to control their phosphate levels annually. If approved, OLC could offer an alternative with improved adherence potential due to its lower pill requirements.