ChemoCentryx Announces FDA Acceptance of the Avacopan New Drug Application (NDA) for the Treatment of ANCA-Associated Vasculitis

-- FDA sets PDUFA goal date of July 7, 2021 --

MOUNTAIN VIEW, Calif., Sept. 17, 2020 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that the U.S. Food and Drug Administration (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 July 7, 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.

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).

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 results in organ damage and failure, with the kidney as the major target, and is fatal if not treated. Currently, treatment for ANCA-associated vasculitis consists of courses of non-specific immuno-suppressants (cyclophosphamide or rituximab), combined with the administration of daily glucocorticoids (steroids) for prolonged periods of time, which can be associated with significant clinical risk including death from infection.