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ChemoCentryx Says FDA Approves Tavneos In ANCA-Associated Vasculitis - Quick Facts

Biopharmaceutical company ChemoCentryx, Inc. (CCXI) announced Friday 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-associated vasculitis or ANCA-associated vasculitis or ANCA vasculitis), specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), 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.

Tavneos is the first FDA-approved orally-administered inhibitor of the complement 5a receptor and it will be available to clinicians and patients in the next few weeks. It is also the first-in-a-decade approval of a medicine for ANCA-associated vasculitis.

The approval in ANCA-associated vasculitis was supported by the results of the pivotal Phase III ADVOCATE trial. This was a global, randomized, double-blind, active-controlled, double-dummy Phase III trial of 330 patients with ANCA-associated vasculitis in 20 countries.

The study met its primary endpoints of disease remission at 26 weeks and sustained remission at 52 weeks, as assessed by the Birmingham Vasculitis Activity Score, or BVAS. The study demonstrated superiority to a prednisone-based standard of care with respect to sustained remission at 52 weeks.

ChemoCentryx is responsible for the discovery and development of Tavneos and owns the commercial rights to the drug in the U.S. Vifor Pharma has exclusive rights to commercialize Tavneos in markets outside of the U.S.

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