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# Panel Split Vote on ChemoCentryx NDA
- URL: https://www.fdaweb.com/panel-split-vote-on-chemocentryx-nda/
- Published: 2021-05-07T12:00:00.000Z
- Updated: 2026-09-14T16:58:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149276

An FDA advisory committee has voted 9 to 9 on whether the efficacy data support approval for a ChemoCentryx NDA for avacopan, indicated for treating adult patients with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. Panel members were mixed on the adequacy of a single Phase 3 trial submitted to support the NDA’s approval.

  
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.”

  
FDA reviewers also raised concerns about the trial’s ability to “adequately justify a margin as the benefit of glucocorticoids when administered with rituximab or cyclophosphamide induction therapy...The utility of a non-inferiority comparison is dependent on knowing that the active control had its expected effect in the non-inferiority study. However, the applicant has not provided adequate data or information that would isolate the effect of prednisone to inform the margin of the non-inferiority comparison in this study.”  

The NDA has a 7/7 user fee review action target date.