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Tavneos
Published
Product name
Tavneos
Active ingredient
Avacopan
Submission type
New entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Tavneos (avacopan) was approved for the following therapeutic use:
Tavneos, in combination with a rituximab or cyclophosphamide based regimen, is indicated for the treatment of adults with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]).
How this medicine works
Avacopan is a selective antagonist of the human complement 5a receptor (C5aR1 or CD88) and competitively inhibits the interaction between C5aR1 and the anaphylatoxin C5a.
The specific and selective blockade of C5aR1 by avacopan reduces the pro-inflammatory effects of C5a, which include neutrophil activation, migration, and adherence to sites of small blood vessel inflammation, vascular endothelial cell retraction and permeability.
Avacopan does not decrease the formation of the membrane attack complex (C5b-9) or terminal complement complex (TCC), which is important in fighting infections with encapsulated bacteria such as Neisseria meningitidis.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Avacopan was considered favourable for the therapeutic use approved.
Sponsor
ARTG details