-- Treatment with avacopan in the absence of daily oral prednisone led to remission at week 26 and superiority in sustaining remission at 52 weeks compared to the prednisone group --
-- Avacopan’s effects on kidney function, patient Quality of Life, and reduction in overall glucocorticoid-related toxicities also described --
-- NDA for avacopan in ANCA-Associated Vasculitis is under review by the FDA with a PDUFA goal date of July 7, 2021 --
MOUNTAIN VIEW, Calif., Feb. 17, 2021 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that The New England Journal of Medicine (NEJM) has published results from ADVOCATE, the pivotal Phase III study evaluating avacopan, an orally-administered selective complement 5a receptor inhibitor, for the treatment of patients with anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis). The publication also featured an editorial titled, “Avacopan — Time to Replace Glucocorticoids?” written by Kenneth J. Warrington, M.D., Chair in the Division of Rheumatology, Department of Internal Medicine at Mayo Clinic in Rochester, Minn.
ANCA-associated vasculitis is a systemic auto-immune disease in which over-activation of the complement system further activates neutrophils, leading to inflammation and eventual 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.
“The results of the ADVOCATE trial are transformational and demonstrate the potential of avacopan to offer a substantial change in the treatment paradigm for ANCA-associated vasculitis,” said Peter A. Merkel, M.D., MPH, Chief of Rheumatology and Professor of Medicine and Epidemiology at the University of Pennsylvania. “Current treatment for ANCA-associated vasculitis consists of combining months of daily glucocorticoids (“steroids” such as prednisone) with other immunosuppressive medications. Use of prednisone is associated with significant side-effects, including infections, diabetes mellitus, weight gain, and other problems. The ability of avacopan to replace prednisone and help patients achieve sustained remission is a significant and exciting advance for the treatment of patients with ANCA-associated vasculitis.”
“The ADVOCATE trial clearly demonstrates avacopan’s ability to improve kidney function, measured by eGFR, in ANCA-associated vasculitis, and was recently reinforced in another orphan kidney disease, C3 Glomerulopathy. This is a significant advantage over other treatment options that often come with added toxicities and will likely lead to reduced risk of kidney failure over the longer term,” said David Jayne, M.D., Director of the Vasculitis and Lupus Service, Addenbrooke’s Hospital in Cambridge.
The ADVOCATE trial was a global, randomized, double-blind, active-controlled, double-dummy Phase III trial in 331 patients with ANCA-associated vasculitis in 20 countries. Eligible patients were randomized to receive either avacopan or oral prednisone. In addition, all patients received standard background therapy of either: (a) rituximab for 4 weeks; or (b) cyclophosphamide for 13 weeks followed by azathioprine/mycophenolate, evenly balanced between the avacopan and prednisone groups.
The study met both of its primary endpoints, demonstrating disease remission at 26 weeks and sustained remission at 52 weeks, as assessed by the Birmingham Vasculitis Activity Score (BVAS). Specifically, BVAS remission at week 26 was achieved in 72.3% of the avacopan treated patients vs. 70.1% of subjects in the prednisone group (p