- Recommendation follows an Article 20 non-pharmacovigilance procedure
- Patients currently on TAVNEOS treatment should consult their treating physician
ST. GALLEN, Switzerland, June 26, 2026 /PRNewswire/ -- Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and CSL announced today 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.
"While we are disappointed in the outcome of the Article 20 procedure, we will respect the outcome of 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," said Dr. Bill Mezzanotte, Head of Research and Development, CSL. "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."
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.
About ANCA-associated vasculitis (GPA/MPA)
Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a life-threatening disease where the body's immune system mistakenly attacks its own blood vessels. This causes inflammation and irreversible organ damage, most frequently to the kidneys, and lungs, and requires treatment to manage the disease. The two main forms are granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). Both disease and treatment burden markedly diminish quality of life for affected patients. The unmet medical need remains high as people living with AAV face significant risk of complications, driven both by the disease and treatment-related adverse effects, including from high dose and/or long-term use of glucocorticoids.
About CSL Vifor
CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 29,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit:?www.cslvifor.com.
About TAVNEOS (avacopan)
TAVNEOS (avacopan) is an orally administered small molecule that is a selective inhibitor of the complement C5a receptor C5aR1. By blocking the receptor (the C5aR) for the pro-inflammatory complement system fragment, C5a on inflammatory cells such as blood neutrophils, TAVNEOS inhibits the ability of those cells to do damage in response to C5a activation, which is known to be the driver of inflammation. Moreover, the selective inhibition by TAVNEOS of only the C5aR1 leaves other immune system responses functioning normally.
TAVNEOS was developed by ChemoCentryx, the NDA holder for TAVNEOS in the US, which was acquired by Amgen in 2022. TAVNEOS is commercialized outside the US in selected countries by CSL, its affiliates and partners pursuant to a collaboration and license agreement between Vifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP) and ChemoCentryx.
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