Sentynl Therapeutics Receives CRL for CUTX-101 NDA from USFDA for Menkes Disease Treatment

Sentynl Therapeutics, a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd., announced that the U.S. Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) relating to its New Drug Application (NDA) for copper histidinate (CUTX-101). The CRL was issued due to findings from a CGMP inspection of the facility where CUTX-101 is manufactured. Zydus has already provided responses to the USFDA's re-inspection demonstrating the facility’s CGMP compliance and is awaiting the Establishment Inspection Report (EIR). Sentynl will request a meeting with the USFDA to discuss the CRL and resubmission of the CUTX-101 NDA. The CRL did not cite any other approvability concerns, nor did it identify any deficiencies in CUTX-101’s efficacy and safety data. Menkes disease is a rare X-linked recessive pediatric genetic disease that impacts an estimated 1 in 34,810 to as high as 1 in 8,664 live male births. CUTX-101 is a subcutaneous injectable formulation of copper histidinate that restores copper homeostasis and maintains copper levels in patients with Menkes disease.