ChemoCentryx Submits New Drug Application to the U.S. FDA for Avacopan in ANCA-Associated Vasculitis

MOUNTAIN VIEW, Calif., July 09, 2020 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (NASDAQ: CCXI) today confirmed that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avacopan for the treatment of patients with ANCA-associated vasculitis.

The Company’s NDA 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.

“We have achieved a major landmark for ChemoCentryx with the submission of the NDA for avacopan in ANCA-associated vasculitis following our highly successful Phase III ADVOCATE trial,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. “There is an urgent need for a non-immunosuppressive, targeted therapy that can achieve and sustain remission in this organ- and life-threatening disease, while reducing the toxicities associated with daily steroid use. Submission of our NDA is a critical step toward addressing this unmet need, as we seek to improve patients’ lives.”

In ANCA-associated vasculitis, avacopan has been granted orphan drug designation by the U.S. FDA and orphan medicinal product designation by the European Commission. ChemoCentryx’s Kidney Health Alliance partner, Vifor Fresenius Medical Care Renal Pharma (VFMCRP) intends to file a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) before the end of 2020.

ChemoCentryx is responsible for the discovery and development of avacopan and owns and retains the commercial rights to the drug in the United States. VFMCRP has an exclusive license to commercialize the drug in all countries outside the United States and has granted KISSEI PHARMACEUTICAL CO LTD., an exclusive sub-license to develop and commercialize the drug in Japan.

About ADVOCATE and ANCA-Associated Vasculitis
The ADVOCATE trial of avacopan was a global, randomized, double-blind, active-controlled, double-dummy Phase III trial of 331 patients with ANCA-associated vasculitis in 20 countries. Eligible study subjects were randomized to receive avacopan plus either rituximab or cyclophosphamide (followed by azathioprine/mycophenolate) or prednisone plus either rituximab or cyclophosphamide (followed by azathioprine/mycophenolate).