The European Medicines Agency (EMA) says its Committee for Medicinal Products for Human Use (CHMP) has started a review of Tavneos, a medicine authorised in the EU for adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
The review follows concerns about the reliability of information from the Advocate study, the main study used to support the medicine’s EU authorisation. For patients and families, reviews like this are a routine part of oversight and are designed to ensure decisions remain based on dependable evidence. People should not stop or change treatment without speaking with their clinical team.
According to the EMA, Tavneos was authorised in January 2022 based largely on the 331‑patient Advocate study, which compared Tavneos with high‑dose corticosteroids, with both given alongside standard treatment (either rituximab or cyclophosphamide followed by azathioprine).
The EMA says the way the study data were handled before authorisation may have affected conclusions about how well the medicine works. This focus on data quality and transparency is also central to ERDERA’s commitment to rigorous clinical research that people living with a rare disease can trust.
The EMA will now assess all available evidence and will recommend whether Tavneos’ EU authorisation should stay as it is, be changed, or be paused or withdrawn. The procedure was started at the request of the European Commission under Article 20 of Regulation (EC) No 726/2004. Read the EMA announcement on the Tavneos review for details, follow updates via EMA news, or contact the Agency using the EMA online enquiry form.