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The EMA’s human medicines committee has started a review of oral complement C5 inhibitor Tavneos, prompted by information that the regulator says raises questions about the integrity of the data from the pivotal ADVOCATE study.
ADVOCATE was the main study submitted in support of the EU approval of Tavneos (avacopan) in 2022 as a treatment for severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), two rare inflammatory conditions of the blood vessels.
Originally developed by ChemoCentryx, which was acquired by Amgen for $3.7 billion in 2022, Tavneos is…