Unicycive receives FDA CRL on OLC application

• Unicycive Therapeutics received an FDA Complete Response Letter for its oxylanthanum carbonate NDA.
• The FDA cited third-party manufacturing deficiencies and raised no safety or efficacy concerns.
• No new clinical data was requested, and labeling discussions are ongoing.

Unicycive Therapeutics (NASDAQ:UNCY) said the U.S. Food and Drug Administration issued a Complete Response Letter for its resubmitted new drug application for oxylanthanum carbonate, a treatment for hyperphosphatemia in chronic kidney disease patients on dialysis.

The company said the FDA’s decision was tied to previously identified third-party manufacturing deficiencies rather than issues with safety or effectiveness.

Unicycive said the regulator did not request additional clinical data and did not raise new concerns about efficacy or safety.

The company added that discussions with the FDA are continuing around labeling and packaging requirements.

Unicycive said oxylanthanum carbonate is being developed to help control elevated phosphate levels in dialysis patients with chronic kidney disease.

The company also said it will continue working with regulators to address the manufacturing issues outlined in the Complete Response Letter.