CSL has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use issued an opinion recommending the revocation of the EU marketing authorisation for TAVNEOS (avacopan) following a review under Article 20 of the handling of data in the pivotal Phase 3 ADVOCATE clinical trial.
TAVNEOS is indicated for the treatment of adults with severe, active anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis, in combination with standard therapies.
It is TGA approved in Australia for use in adults with ANCA‑associated vasculitis in combination with a rituximab‑ or cyclophosphamide‑based regimen.
The therapy was developed by ChemoCentryx and commercialised outside the US by CSL and partners under a 2016 collaboration and licence agreement between Vifor Fresenius Medical Care Renal Pharma and ChemoCentryx.
Amgen acquired ChemoCentryx in 2022, and the ADVOCATE trial was conducted by ChemoCentryx prior to CSL’s acquisition of Vifor Pharma in 2022.
The European Commission (EC) will now review the Committee opinion and issue a final decision in due course.
In response, CSL said it expects to cease new patient initiation in the EU and European Economic Area (EEA) markets pending the EC decision and consistent with regulatory guidance.
Sales revenue from TAVNEOS for the financial year 2026 is expected to be approximately $145 million. CSL said further details, including impairment of TAVNEOS intellectual property, will be provided in its 2026 Full Year results in August 2026.
Dr Bill Mezzanotte, CSL’s Head of Research and Development, said, “While we are disappointed in the outcome of the Article 20 procedure, we will respect the regulatory process and are committed to implementing it in full. We recognise this is a difficult moment for the community, as TAVNEOS has played an important role for patients living with ANCA-associated vasculitis, a life-threatening disease with limited treatment options. VFMCRP and CSL remain focused on bringing innovative treatment options to patients living with rare diseases.
“Patient care remains our highest priority, and we are working closely with regulatory authorities, healthcare professionals and patient organisations to ensure a compliant and appropriate treatment transition, along with ongoing support for patients.”
