The European Commission has revoked the EU marketing authorisation for TAVNEOS (avacopan) for ANCA-associated vasculitis after concluding that a positive benefit-risk balance could no longer be established following a CHMP review.
Written By: Shaik Yasmeen, PharmD
Reviewed By: Pharmacally Editorial Team
The European Commission has revoked the marketing authorisation for TAVNEOS® (avacopan), ending its availability across the European Union (EU) and European Economic Area (EEA) for the treatment of adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). The decision follows the CHMP recommendation issued on June 26, 2026, after a regulatory review concluded that the therapy’s benefit-risk profile could no longer be considered positive.
TAVNEOS had been approved for use in combination with rituximab or cyclophosphamide for adults with severe active ANCA-associated vasculitis (AAV). The drug was originally developed by ChemoCentryx, which was acquired by Amgen in 2022, and is commercialized outside the United States and in selected countries by Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and its partners.
Regulatory Review Triggered by ADVOCATE Trial Data Concerns
The EC decision stems from an Article 20 non-pharmacovigilance procedure, initiated after concerns emerged regarding data handling in the pivotal Phase 3 ADVOCATE trial before the medicine received marketing approval.
Following its review, the CHMP concluded that available evidence no longer supported a favorable benefit-risk balance for TAVNEOS. Based on this assessment, the European Commission formally revoked the marketing authorisation across the EU and EEA.
As a result, TAVNEOS can no longer be prescribed in these regions. Physicians caring for patients currently receiving avacopan have been advised to reassess treatment plans and determine appropriate alternative therapies based on individual clinical needs.
TAVNEOS and the Treatment of ANCA-Associated Vasculitis
TAVNEOS (avacopan) is an oral complement 5a receptor (C5aR) antagonist that targets activation of the complement pathway implicated in ANCA-associated vasculitis. By blocking C5a receptor signaling, the therapy was developed to reduce neutrophil-driven inflammation while limiting reliance on prolonged high-dose glucocorticoids.
ANCA-associated vasculitis is a rare, life-threatening autoimmune disease in which the immune system attacks small blood vessels, causing inflammation and irreversible organ damage. The kidneys and lungs are among the organs most commonly affected. The two principal forms of the disease are GPA and MPA.
Despite advances in treatment, patients continue to face substantial disease burden, frequent relapses, and complications associated with long-term corticosteroid exposure, highlighting the persistent unmet medical need in AAV.
Companies Outline Transition Plan
VFMCRP and CSL stated they respect the outcome of the European regulatory process and will work closely with the EMA and national health authorities to implement the withdrawal across affected countries.
The companies emphasized that patient care remains the highest priority during the transition. Country medical teams and medical information services will support healthcare professionals and patient communities as prescribing of TAVNEOS is discontinued. Patients currently receiving the therapy are encouraged to consult their treating physicians to discuss individualized treatment strategies.
Future Development
The revocation applies specifically to the European Union and European Economic Area following the EC decision. The action concludes the Article 20 regulatory review initiated over concerns related to the integrity of data handling in the ADVOCATE Phase 3 trial rather than new pharmacovigilance findings.
The decision marks a significant regulatory setback for avacopan in Europe and underscores the importance of clinical trial data integrity in maintaining regulatory confidence. Healthcare providers across the region will now transition eligible patients to alternative treatment approaches while regulators and manufacturers oversee the orderly withdrawal of the product from clinical use.
Reference
A further update on TAVNEOS® (avacopan) in the European Union
About the Writer
Shaik Yasmeen (LinkedIn) is a Pharm.D graduate with interests in clinical pharmacy, pharmacovigilance, and medical writing. She has gained experience through hospital clinical postings, patient case reviews, case presentations, and literature evaluation. Passionate about evidence-based healthcare, she is committed to creating accurate and engaging medical content while continuously expanding her professional knowledge.
