Vifor Fresenius Medical Care Renal Pharma (VFMCRP), a Swiss pharmaceutical company, and CSL, an Australian biopharmaceutical company, announced on Friday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the revocation of the European Union (EU) marketing authorisation for TAVNEOS (avacopan).

TAVNEOS is a treatment for adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), which are the main forms of ANCA-associated vasculitis. TAVNEOS is indicated for use in combination with rituximab or cyclophosphamide.

The CHMP opinion has been provided to the European Commission (EC), and a final decision by the EC is expected shortly. If this recommendation is confirmed by the European Commission, TAVNEOS will no longer be authorised in the EU.

The recommendation to revoke the marketing authorisation is based on a review of TAVNEOS under an Article 20 non-pharmacovigilance procedure that was initiated due to concerns related to data handling in the pivotal Phase 3 ADVOCATE trial. TAVNEOS was developed by ChemoCentryx and is commercialised outside the US and in selected countries by CSL, its affiliates and partners pursuant to a collaboration and license agreement between Vifor Fresenius Medical Care Renal Pharma Ltd. and ChemoCentryx. Amgen acquired ChemoCentryx in 2022.

No new patients will be treated with TAVNEOS in the EU and the European Economic Area. Patients currently on TAVNEOS are advised to consult with their physician.