After Unicycive Therapeutics had its drug application for oxylanthanum carbonate (OLC) turned away by the FDA a year ago on manufacturing grounds, the company may be experiencing a case of déjà vu with its latest rejection.
The FDA has issued a complete response letter to Unicycive over the “same third-party manufacturing deficiencies that were identified in the previous CRL issued in June 2025,” the company said in a June 30 release. The company is announcing this CRL one year later to the day from its prior CRL disclosure last June.
Tuesday, Unicycive stressed that the FDA has not raised questions over the clinical and safety data in its filing for OLC. The company is seeking approval for the candidate as a treatment for hyperphosphatemia in patients with chronic kidney disease on dialysis.
After its prior rejection, the company held a Type A meeting with the FDA to “obtain feedback and alignment on resolving the deficiencies identified” in the prior CRL, Unicycive said in today’s release. The company then resubmitted the drug approval filing based on the “belief of continued progress” at the third-party manufacturer.
As Unicycive understands it, the third-party manufacturer has not been reinspected as part of the resubmitted approval filing.
“We are in active and ongoing discussion with the FDA regarding label and packaging, and we are optimistic that there will be a successful inspection of the third-party manufacturing vendor and that we will be able to expeditiously resubmit the NDA,” Unicycive CEO Shalabh Gupta, M.D., said in a statement.
The biopharma is one of many to have suffered a recent manufacturing-related complete response letter. Just yesterday, Sobi and Lantheus had their approval bids turned away over manufacturing concerns.
Prior to those, AbbVie and Grace Therapeutics were hit with CRLs in quick succession, with both documents citing manufacturing concerns. And in March, Incyte’s filing for PD-1 inhibitor Zynyz suffered a similar fate thanks to continued issues at a Novo Nordisk plant in Indiana.