Complete Response Letter from FDA review of NDA for ACER 001 for urea cycle disorders.
Acer Therapeutics Inc. and its collaboration partner, Relief Therapeutics Holding SA announced that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ACER 001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders (UCDs).
The CRL indicates that the FDA cannot approve the NDA in its current form. The CRL states: “[The FDA’s] field investigator could not complete inspection of [Acer’s third-party contract packaging manufacturer], because the facility was not ready for inspection. Satisfactory inspection is required before [the NDA] may be approved. Please notify us in writing when this facility is ready for inspection.”
The FDA did not cite any other approvability issues in the CRL pertaining to the NDA, nor request any additional clinical or pharmacokinetic studies be conducted prior to FDA approval.
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