US FDA rejects approval of Unicycive’s kidney disease therapy

The US FDA has declined to approve Unicycive Therapeutics’ resubmitted NDA for OLC to treat hyperphosphatemia in CKD patients on dialysis. The FDA did not raise concerns related to the clinical efficacy or safety data provided for OLC. The CRL cited deficiencies at a third-party manufacturing facility producing the therapy. Credit: Gorodenkoff/Shutterstock.com. The US Food and Drug Administration (FDA) has declined to approve Unicycive Therapeutics’ resubmitted new drug application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. This decision was issued in a Complete Response Letter (CRL) which cited deficiencies at a…

Source: Pharmaceutical Technology