Posted by Michael Wonder on 09 Jul 2020
ChemoCentryx submits new drug application to the U.S. FDA for avacopan in ANCA associated vasculitis
9 July 2020 - ChemoCentryx today confirmed that the Company has submitted a new drug application to the U.S. FDA for avacopan for the treatment of patients with ANCA associated vasculitis.
The Company’s submission is supported by the results of its pivotal 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 in this serious and life-threatening disease, with fewer subjects having serious adverse events in the avacopan group than in the prednisone group.
