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ChemoCentryx Announces FDA Approval of TAVNEOS™ (avacopan) in ANCA-Associated Vasculitis
-- First FDA-approved orally-administered inhibitor of the complement 5a receptor -- -- Company to hold conference call at 8:30 a.m. Eastern Time -- SAN
About this update from Chemocentryx Inc.
[{"type":"text","content":"-- First FDA-approved orally-administered inhibitor of the complement 5a receptor -- -- Company to hold conference call at 8:30 a.m. Eastern Time -- SAN CARLOS, Calif., Oct. 08, 2021 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that the U.S. Food and Drug Administration (FDA) has approved TAVNEOS (avacopan), an orally administered selective complement 5a receptor inhibitor, as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (also known as ANCA-associated vasculitis or ANCA vasculitis), specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms of ANCA vasculitis), in combination with standard therapy. ANCA-associated vasculitis is a systemic autoimmune 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 often fatal if not treated. “Today is a momentous day in the history of ChemoCentryx; the culmination of decades of effort aimed at offering new hope to patients with this and other debilitating and deadly diseases,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. “We look forward to making TAVNEOS available to clinicians and patients in the next few weeks. We thank the Agency for their collaboration and consideration and we are also immensely grateful to the pioneering scientists, clinicians and patients who believed in the promise of TAVNEOS and who have worked tirelessly to make it a reality, along with my dedicated and talented colleagues at ChemoCentryx.” “I am excited that our work has helped lead to the first-in-a-decade approval of a medicine for ANCA-associated vasculitis. This is an important step forward in the treatment of this disease,” said the trial’s co-primary academic investigator Peter A. Merkel, MD, MPH, the Chief of Rheumatology at the Perelman School of Medicine at the University of Pennsylvania, Director of the international Vasculitis Clinical Research Consortium, and consultant to ChemoCentryx. “Patients will now have access to a new class of medication that provides beneficial effects for the treatment of ANCA-associated vascul...