TGA review of the benefits and risks of TAVNEOS (avacopan)

The Therapeutic Goods Administration (TGA) is undertaking a review of the benefits and risks of TAVNEOS (avacopan). TAVNEOS (avacopan) is a medicine used in the treatment of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, a rare autoimmune condition that affects small blood vessels.

The TGA is reviewing new information that has raised concerns regarding the integrity and reliability of the clinical trial data that supported the approval of TAVNEOS (avacopan) in Australia. The purpose of this review is to assess the efficacy and safety of TAVNEOS (avacopan) in light of this new information. The TGA is also aware of the recent media and international regulatory action in relation to this matter.

The TGA will provide further information, including any updated advice for healthcare professionals and patients when available.

Decisions about treatment should be made in consultation with a healthcare professional who can consider an individual patient's clinical circumstances.

Healthcare professionals should carefully consider the benefits and risks of TAVNEOS (avacopan) on an individual patient basis. See the Product Information for TAVNEOS (avacopan) for more information.

Consumers and healthcare professionals are encouraged to report any suspected adverse events associated with TAVNEOS (avacopan) to the TGA. Adverse event reports contribute to the TGA's ongoing monitoring of the safety of medicines and can assist in the identification and investigation of potential safety signals. Consumers, health professionals and sponsors can find information on reporting an adverse event on our website: Report an adverse event or safety problem.