FDA Accepts Unicycive's NDA for Oxylanthanum Carbonate in CKD Patients on Dialysis
核心洞察
The FDA has accepted Unicycive Therapeutics' New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for hyperphosphatemia (搜索) in chronic kidney disease (CKD (搜索)) patients on dialysis.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025, for the OLC application.
Unicycive is seeking approval via the 505(b)(2) regulatory pathway, supported by data from three clinical studies and preclinical data.
Unicycive Therapeutics, Inc. (UNCY) has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for the treatment of hyperphosphatemia (搜索) in patients with chronic kidney disease (CKD (搜索)) undergoing dialysis. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025.
Potential Impact of OLC
If approved, OLC holds the potential to significantly alleviate the treatment burden for hyperphosphatemia (搜索) in CKD (搜索) patients on dialysis. Unicycive is preparing for the commercialization and launch of OLC in the latter half of 2025, contingent upon FDA approval.
Regulatory Pathway and Supporting Data
Unicycive is pursuing FDA approval for OLC through the 505(b)(2) regulatory pathway. The NDA submission is supported by data derived from three clinical studies, including a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study in CKD (搜索) patients on dialysis. The submission also includes multiple preclinical studies, as well as chemistry, manufacturing, and controls (CMC) data.
Intellectual Property
OLC is protected by a robust global patent portfolio, including issued patents on composition of matter providing exclusivity until 2031, with the potential for patent term extension until 2035.
Financial Considerations
Notably, the FDA previously granted a waiver for the NDA application PDUFA fees, resulting in substantial savings of approximately $4 million for Unicycive.