USFDA accepts Shilpa Medicare CDMO partner Unicycive NDA for Oxylanthanum Carbonate
Karnataka: Shilpa Medicare CDMO partner Unicycive Therapeutics, Inc. 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.
CKD refers to the gradual loss of kidney function over time. The kidneys play a vital role in filtering waste products and excess fluids from the blood, regulating blood pressure, balancing electrolytes, and producing hormones that influence red blood cell production and calcium metabolism. When kidney function declines, waste can build up in the body, leading to serious health complications.
Unicycive has entered into a long term manufacturing contract with Shilpa 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.
Shilpa is an integrated pharmaceutical group with business interests in niche Oncology & Non-oncology APIs, Peptides, Polymers, differentiated finished dosage formulations including orally dispersible films & transdermal patches along with carefully crafted biological portfolio. Shilpa also provides end-to-end CDMO services to global pharmaceutical companies across all its business segments based on its strong R&D and manufacturing capabilities backed by four R&D units and seven manufacturing facilities.
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