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FDA advisory committee votes on recommending CCX 168 for approval in vasculitis.- ChemoCentryx

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Last updated:24th Sep 2021
Published:8th May 2021
ChemoCentryx announced the outcome of the FDA Arthritis Advisory Committee on CCX 168 (avacopan) for the treatment of Antineutrophil Cytoplasmic Autoantibody (ANCA)-associated vasculitis (or AAV).
ChemoCentryx announced the outcome of the FDA Arthritis Advisory Committee on CCX 168 (avacopan) for the treatment of Antineutrophil Cytoplasmic Autoantibody (ANCA)-associated vasculitis (or AAV). In the final part of the public meeting, the Committee voted on three questions presented by the FDA. The Committee vote split 9-9 on the first question, whether the efficacy data support approval of avacopan for the treatment of adult patients with AAV (granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)). On the second question, the Committee voted 10-8 that the safety profile of avacopan is adequate to support approval of avacopan for the treatment of adult patients with AAV (GPA and MPA). In the third and final question, the Committee voted 10-8 that the benefit-risk profile is adequate to support approval of avacopan at the proposed dose of 30 mg twice daily for the treatment of adult patients with AAV (GPA and MPA). The FDA has set 7 July 2021 as the Prescription Drug User Fee Act (PDUFA) goal date for the avacopan NDA.
Condition: Vasculitis
Type: drug