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

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

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

Shots:

  • 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

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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