On September 27, ChemoCentryx, Vifor Pharma, and Kissei Pharmaceutical jointly announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan has approved the first-in-class oral small molecule complement C5a receptor inhibitor Tavneos (avacopan) to be marketed. It is used to treat two main types of anti-neutrophil cytoplasmic autoantibody (ANCA)-related vasculitis: microscopic polyangiitis (MPA) and granuloma with polyangiitis (GPA). This is the first time this C5aR inhibitor has been approved globally.

ANCA-related vasculitis is a systemic disease. Excessive activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels, causing damage and failure of organs such as kidneys. At present, the treatment of this disease includes non-specific immunosuppressant (cyclophosphamide or rituximab) treatment, and long-term daily daily glucocorticoids (steroids), which may cause major clinical risks, including death from infection.

Avacopan uses a novel and highly targeted mechanism of action in the treatment of ANCA-related vasculitis and other complement-driven autoimmune and inflammatory diseases. It avoids upstream complement inhibition, does not hinder the production of C5b-9, retains the body's defense mechanism (MAC), and also retains the beneficial functions of the C5L2 pathway.

On July 6 this year, ChemoCentryx announced that the PDUFA target date for avacopan's new drug application in the United States has been extended to October 7, 2021. The PDUFA date for avacopan NDA application was originally July 7, 2021.