Unicycive Therapeutics provides update on NDA for oxylanthanum carbonate

Unicycive Therapeutics (UNCY) provided an update on its New Drug Application, or NDA, for oxylanthanum carbonate -OLC – to treat hyperphosphatemia in patients with chronic kidney disease, or CKD, on dialysis. The FDA communicated to the company that it had identified deficiencies in cGMP compliance at a third-party manufacturing vendor – one of its CDMO’s third-party subcontractors and not its Drug Substance vendor – following an FDA inspection. The FDA indicated that, given the identified deficiencies, any label discussions between the FDA and the company are precluded. The company has responded to all FDA information requests and expects a final decision from the FDA by the PDUFA action date of June 28. Unicycive is seeking FDA approval of OLC via the 505(b) regulatory pathway. OLC is protected by a global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.