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Unicycive Therapeutics Announces U.S. FDA Acceptance of the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis
Unicycive Therapeutics announced FDA acceptance of its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients on dialysis. The FDA set a PDUFA target date of June 28, 2025. OLC aims to reduce treatment burden by requiring fewer and smaller pills that can be swallowed rather than chewed. The NDA submission includes data from three clinical studies and is seeking approval via the 505(b)(2) pathway. The company received an FDA fee waiver, saving approximately $4 million, and is preparing for commercial launch in second half of 2025 if approved.
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