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Amendment filed to FDA for CCX 168 in vasculitis and PUDFA goal date delayed.- ChemoCentryx

Read time: 1 mins
Last updated:29th Jul 2021
Published:7th Jul 2021
ChemoCentryx announced that, following consultations with the FDA, it filed an amendment to its New Drug Application (NDA) for CCX 168 (avacopan) for the treatment of Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated vasculitis, addressing points raised during the FDA Advisory Committee meeting on May 6, 2021. The FDA has indicated that the filing constitutes a major amendment to the NDA and will result in the setting of a new PDUFA goal date of October 7, 2021.
Condition: Vasculitis
Type: drug
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