The U.S. FDA has issued a complete response letter for Unicycive Therapeutics’ new drug application for oxylanthanum carbonate (OLC) tablets to treat hyperphosphatemia in patients with chronic kidney disease on dialysis, citing deficiencies identified at a third-party manufacturing vendor.
According to Unicycive, the FDA has previously notified the company that a third-party manufacturing vendor of its main CDMO was cited for deficiencies following a CGMP inspection. The citation, says the company, is unrelated to OLC. The agency did not flag any other technical concerns related to the submitted CMC documentation or testing of OLC itself.
“We plan to immediately seek a Type A meeting with the agency to gain alignment on the best strategy to ensure rapid resolution of the CRL,” said Shalabh Gupta, M.D., CEO of Unicycive.
Unicycive has already identified a second manufacturing vendor that has a “long history of successful FDA and international regulatory inspections and has already produced OLC drug product.”
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 (high levels of phosphate in the blood) in patients with chronic kidney disease on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden.