avacopan + rituximab

Tavneos + rituximab is a combination regimen consisting of avacopan (Tavneos), an orally administered small molecule selective antagonist of the complement C5a receptor (C5aR1), and rituximab (Rituxan), an intravenously administered anti-CD20 monoclonal antibody. This combination is used as an induction therapy for adult patients with severe active antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV), specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). Avacopan blocks C5a-mediated neutrophil activation and migration to reduce vascular inflammation, while rituximab depletes B cells to suppress autoantibody production. This regimen is designed to achieve disease remission while reducing or eliminating the need for standard glucocorticoid therapy. However, in 2026, regulatory agencies including the US FDA, UK MHRA, and Australian TGA proposed or initiated the withdrawal or suspension of Tavneos due to concerns over the integrity of the pivotal Phase 3 ADVOCATE trial data and risks of serious drug-induced liver injury, including vanishing bile duct syndrome.

Other names

Tavneos + RituxanTavneos + rituximabTavneos and rituximabTavneos plus rituximabavacopan and rituximabavacopan plus rituximab