The U.S. Food and Drug Administration (FDA) has accepted Unicycive Therapeutics' New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025.
Addressing Treatment Burden in CKD Patients
Hyperphosphatemia, a common complication in CKD patients on dialysis, often requires a complex treatment regimen involving multiple pills daily. Patients may need to take as many as 12 pills per day to manage their phosphate levels. OLC is designed to reduce this burden by offering a lower pill count and easier administration, potentially leading to better patient adherence compared to existing treatments.
Potential for Improved Adherence
OLC offers a significant advantage in terms of patient convenience. The pills are designed to be swallowed rather than chewed, adding to the ease of administration. This simplified regimen is expected to improve adherence among patients who often struggle with the demanding pill schedules of current hyperphosphatemia treatments.
Manufacturing and Commercialization
Unicycive has partnered with Shilpa Medicare for the commercial manufacturing of OLC. A long-term manufacturing contract is in place to ensure a steady supply of the drug upon FDA approval. Unicycive anticipates launching OLC in the U.S. market in the second half of calendar year 2025, pending FDA approval.
