Acer Therapeutics and Relief Receive the US FDA’s CRL for ACER-001’s NDA to Treat Urea Cycle Disorders


The US FDA has issued a CRL citing the requirement to examine a third-party contract packaging manufacturer & NDA for ACER-001 to treat UCDs
The US FDA has not raised any approvability concerns related to the efficacy, safety & PK of ACER-001 & did make a note in the CRL asking for further nonclinical data to be included in the NDA when it will be resubmitted
Acer is planning to resubmit the updated NDA of ACER-001 for oral suspension to treat UCDs in early-to-mid Q3’22. ACER-001 is a nitrogen-binding agent & is being developed for use as adjuvant therapy for UCDs affecting CPS, OTC, or AS & has received ODD from the US FDA for MSUD

Ref: GlobalNewire | Image: Acer Therapeutics

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