Vifor Fresenius Medical Care Renal Pharma announced that the European Commission has approved Tavneos in combination with a rituximab or cyclophosphamide regimen for the treatment of adult patients with severe, active granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA), the two main forms of ANCA-associated vasculitis. The approval is consistent with expectations and overall follows the U.S. Food and Drug Administration (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.
“The European Commission’s approval of Tavneos is a milestone for the treatment of ANCA-associated vasculitis in Europe and for patients living with this debilitating disease,” said Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma. “We are confident that Tavneos can become part of the new standard of care supporting better outcomes for patients, a better quality of life, and reduce the challenging side-effects of current treatment options. We look forward to working with EU member states to provide access to this important medicine, with first launches expected in the first half of 2022.”
“This is a significant step forward for patients in Europe living with this systemic condition,” said Prof. David Jayne, Professor of Clinical Autoimmunity, University of Cambridge. “They will now have available a new class of medication that meets major unmet medical needs in the treatment of ANCA-associated vasculitis.”
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.