ChemoCentryx announces FDA acceptance of the avacopan NDA for the treatment of ANCA-associated vasculitis.

ChemoCentryx, Inc., announced that the FDA has accepted the Company’s New Drug Application (NDA) for avacopan, an orally-administered selective complement 5a receptor inhibitor, for the treatment of ANCA-Associated Vasculitis and has set 7 July 2021 as the Prescription Drug User Fee Act (PDUFA) goal date for the avacopan NDA. Avacopan is a first-in-class, orally administered therapy that employs a novel, highly targeted mode of action in the treatment of ANCA-associated vasculitis. In its NDA acceptance letter, the FDA also indicated that it may, but has not yet determined whether to hold an advisory committee meeting to discuss the application per guidelines for new molecular entities. The NDA included data from the global, Phase III ADVOCATE trial, which demonstrated statistical superiority in sustaining remission at 52 weeks in the avacopan group compared to the prednisone group. In the trial, 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. Finally, avacopan demonstrated favorable safety results, with fewer patients having serious adverse events in the avacopan group than in the prednisone group.