Unicycive receives CRL for oxylanthanum carbonate NDA for hyperphosphatemia

Unicycive Therapeutics (UNCY) announced that the U.S. Food and Drug Administration has issued a CRL for its New Drug Application for OLC to treat hyperphosphatemia in patients with chronic kidney disease on dialysis. After submitting the NDA, and as a part of the application review and routine information requests, the FDA notified Unicycive that a third-party manufacturing vendor of its main contract development and manufacturing organization was cited for deficiencies following a cGMP inspection. This citation is unrelated to OLC. Unicycive also notes that as part of the NDA review, the Agency has not highlighted any other technical concerns related to the submitted CMC documentation or testing of OLC itself. As part of its overall manufacturing strategy, the Company had previously identified a back-up third-party manufacturing vendor to build redundancy into its supply chain. The second vendor has a long history of successful FDA and international regulatory inspections and has already produced OLC drug product, which could also be used to support the resolution of the CMC issues identified in the CRL.