EMA starts review of Tavneos, a medicine for rare auto-immune diseases GPA and MPA

EMA

30 January 2026 - The EMA’s CHMP has started a review of Tavneos (avacopan), following emerging information that raises questions regarding the data integrity of the Advocate study, which was the main study supporting the medicine’s marketing authorisation in the European Union.

Tavneos was authorised in the EU in January 2022 for treating adults with severe, active granulomatosis with polyangiitis or microscopic polyangiitis, two rare inflammatory conditions of the blood vessels.

Read EMA press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , Regulation , Safety