The European Medicines Agency (EMA) has begun a review of Tavneos (avacopan) following emerging questions about the data integrity of the Advocate study, which supported its EU marketing authorization. Tavneos, approved in January 2022 for treating severe granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), was compared in the Advocate study to high-dose corticosteroids in 331 patients. Concerns focus on how data from the study was handled prior to authorization, potentially impacting effectiveness findings. EMA will assess whether this information affects the benefit-risk balance and determine if authorization should remain, be amended, suspended, or revoked. The review, initiated by the European Commission under Article 20 of Regulation (EC) No 726/2004, will be conducted by the CHMP committee before a final decision is made.
© European Medicines Agency (1995‑).
Summary adapted from EMA materials available at https://www.ema.europa.eu
https://www.ema.europa.eu/en/news/ema-starts-review-tavneos-medicine-rare-autoimmune-diseases-gpa-mpa
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