This site is intended for healthcare professionals

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
Register for free access to this exclusive healthcare learning resource

Why sign up with Medthority?

Develop your knowledge with our disease and condition focused Learning Zones

Access content from credible sources, including expert-led commentary, videos, podcasts, and webinars as well as clinical trials, treatment information and guidelines 

Personalised dashboard providing updates and recommendations for content within your areas of interest