India, June 30 -- Unicycive Therapeutics, Inc. (UNCY), announced that the U.S. FDA issued a Complete Response Letter (CRL) regarding the resubmitted New Drug Application (NDA) for oxylanthanum carbonate (OLC), a therapy for hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
The FDA did not raise concerns about clinical efficacy or safety data and requested no additional data. The CRL instead relates to deficiencies previously identified at a third-party manufacturing vendor, which has not yet undergone FDA inspection during the NDA resubmission review. Labelling discussions are ongoing, with the agency recently providing feedback on carton and container packaging.
Hyperphosphatemia is a condition characterized by...