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# ChemoCentryx NDA Amendment for Avacopan
- URL: https://www.fdaweb.com/chemocentryx-nda-amendment-for-avacopan/
- Published: 2021-07-06T12:00:00.000Z
- Updated: 2026-09-14T17:05:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149635

ChemoCentryx has filed an amendment to its NDA for avacopan for treating anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. The submission is intended to address advisory committee concerns that led to a split vote during a 5/6 meeting ([see earlier story](https://www.fdaweb.com/panel-split-vote-on-chemocentryx-nda/)). The submission triggers a three-month user fee review extension and the new action date is 10/7.

The committee voted 9 to 9 on whether the efficacy data support NDA approval, with panel members mixed on the adequacy of a single Phase 3 trial submitted to support the submission. In an FDA [briefing document](https://www.fda.gov/media/148176/download?ref=fdaweb.com), agency reviewers said there are “substantial uncertainties around the Phase 3 study design and results, raising questions about the adequacy of this single trial to inform the benefit-risk assessment.” While the study demonstrated avacopan’s non-inferiority to a pre-specified prednisone taper at Weeks 26 and 52 with both arms receiving background therapy and glucocorticoids, FDA said that a “non-inferiority comparison would not be sufficient to show that avacopan can replace glucocorticoids as it would be difficult to distinguish whether avacopan is effective or whether the induction treatment with rituximab/cyclophosphamide was the primary driver of the efficacy in both treatment arms.”

ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels, the company says. This results in organ damage and failure, with the kidney as the major target a could become fatal if not treated.