EMA approves Tavneos for ANCA-associated vasculitis.
The approval is consistent with expectations and overall follows the FDA approval of Tavneos in October 2021 for the same indication. Tavneos will receive marketing authorization in all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
EU approval is based on a comprehensive development program, culminating in the results from the pivotal phase-III trial ADVOCATE in 331 patients with ANCA-associated vasculitis in 20 countries, comparing treatment regimens including Tavneos to current standard of care treatment regimens with high dose glucocorticoid use. The study met its primary endpoints of disease remission at week 26 and sustained remission at week 52, as assessed by the Birmingham Vasculitis Activity Score (BVAS). Tavneos demonstrated superiority over standard of care at week 52.
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