FDA Accepts Acer's Inborn Metabolism Disorder Therapy Refiling For Review

FDA Accepts Acer's Inborn Metabolism Disorder Therapy Refiling For Review

The U.S. Food and Drug Administration (FDA) has accepted for review Acer TherapeuticsACER resubmission of New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for oral suspension in the treatment of patients with urea cycle disorders (UCDs).

The regulatory agency designated the new drug application as a Class 2 resubmission and assigned a target action date of January 15, 2023.

Earlier in Jun 2022, the agency has issued a Complete Response Letter (CRL) indicating satisfactory inspection of company’s third-party contract packaging manufacturer is required before the NDA may be approved.

Chris Schelling, Founder & Chief Executive Officer, commented: "We have notified the FDA that our third-party contract packaging manufacturer is ready for inspection and are hopeful that the Agency's review can be completed in a timely manner. While NDA approval is not assured, if approval is received, we are prepared to execute on our comprehensive launch plan and provide a new treatment option to underserved UCDs patients.”

The company has provided additional existing nonclinical information as requested by the FDA in the CRL as well as labeling and other required updates, in the resubmission of the NDA.

Price Action : Acer Therapeutics shares are trading around 2 percent higher at $1.46 on Thursday at the time of publication

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