(RTTNews) - Biotechnology company Unicycive Therapeutics, Inc. (UNCY) announced Monday that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025.
If approved, OLC has the potential to meaningfully improve the treatment burden for hyperphosphatemia patients with chronic kidney disease (CKD) on dialysis. The company is preparing to commercialize and launch OLC in the second half of 2025, if approved.
Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data.
OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
As previously announced, the FDA granted a waiver for the NDA application PDUFA fees, representing a significant savings of approximately $4 million for Unicycive.
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