Australian Regulator Initiates Review of TAVNEOS (avacopan) Amid Clinical Trial Data Integrity Concerns

The Therapeutic Goods Administration (TGA) in Australia has commenced a review of the benefits and risks of TAVNEOS (avacopan), a medicine for ANCA-associated vasculitis. This action follows new information raising concerns about the integrity and reliability of the clinical trial data that supported its approval. The TGA is assessing the drug's efficacy and safety in light of these issues, which have also led to international regulatory actions and a significant cut in sales forecasts by manufacturer Kissei Pharmaceutical.