October 8. 2021
ChemoCentryx Announces FDA Approval of TAVNEOS™ (avacopan) in ANCA-Associated Vasculitis
ChemoCentryx announced today that the U.S. Food and Drug Administration (FDA) has approved TAVNEOS (avacopan) as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV), and specifically for granulomatosis with polyangiitis and microscopic polyangiitis, the two main forms of AAV. AAV is a group of autoimmune diseases that causes blood vessels to swell. The vessels involved in AAV are typically capillaries, arterioles and venules but small arteries and veins may also be involved.
AAV affects people of all ages and there is no cure. Current treatment has consisted of combining months of daily glucocorticoids (i.e., 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, which demonstrates the importance of why new treatments are needed.
“We are pleased with the approval of avacopan as there are currently limited treatment options available for patients with AAV that avoid the long-term and oftentimes devastating effects of glucocorticoids,” said Sara Baird Amodio, MSW, EdD, President, VF Board of Directors. “We welcome the news that avacopan will now offer patients with AAV and healthcare providers a novel treatment option to address an unmet need for a glucocorticoid-free therapeutic approach.”
Avacopan is a selective complement 5a receptor inhibitor and orally-administered therapy that uses a novel, highly-targeted mode of action in the treatment of AAV. Results from ADVOCATE, the pivotal Phase III study evaluating avacopan, were published in The New England Journal of Medicine earlier this year. 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 received either avacopan or oral prednisone. All patients received either rituximab for four weeks or cyclophosphamide for 13 weeks followed by azathioprine/mycophenolate, evenly balanced between the avacopan and prednisone groups. Avacopan showed promising results with fewer subjects having serious adverse events in the avacopan group than in the prednisone group.
“We want to thank the physicians and researchers who worked on this study and the patients who participated to make it possible,” added Joyce A. Kullman, Executive Director of the VF. “Our patients need and deserve more effective treatment options. We are excited to know that there is hope for our patients.”