USFDA accepts Unicycive Therapeutics' NDA for Oxylanthanum Carbonate
Unicycive Therapeutics, Inc. (NASDAQ: UNCY) has announced that the U.S. Food and Drug Administration (USFDA) has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) and 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.
CKD patients on dialysis with hyperphosphatemia are often saddled with an onerous treatment regimen that includes having to take as many as 12 pills per day. OLC is likely to result in better patient adherence over currently available treatment options as it requires a lower pill burden in terms of the number and size of pills per dose, and the pills are swallowed instead of chewed for added convenience.
Unicycive has entered into a long term manufacturing contract with Shilpa Medicare for the supply of the product at commercial scale once approved by the USFDA. With Unicycive's NDA now under review, it is expected to commercialize and launch OLC in the US market in the second half of calendar year 2025.
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