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# ChemoCentryx NDA Accepted for Avacopan
- URL: https://www.fdaweb.com/chemocentryx-nda-accepted-for-avacopan/
- Published: 2020-09-17T12:00:00.000Z
- Updated: 2026-09-14T16:29:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147674

FDA has accepted for review a ChemoCentryx NDA for avacopan, an orally-administered selective complement 5a receptor inhibitor for treating antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The agency has set a 7/7 user fee review action target date.

The company says 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. This can result in organ damage and failure, with the kidney as the major concern, it says.

The NDA included data from the global, Phase 3 ADVOCATE trial, the company says, which demonstrated statistical superiority in sustaining remission at 52 weeks in the avacopan group compared to the prednisone group. The avacopan group also showed significantly lower glucocorticoid toxicity, greater improvement in kidney function and greater improvement in health-related quality of life measures compared to the prednisone group, it adds. On the safety side, avacopan demonstrated favorable safety results, with fewer patients having serious adverse events in the avacopan group than in the prednisone group.