ST. GALLEN, SWITZERLAND – 6 August, 2026 Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and CSL announced today that the European Commission (EC) has adopted the decision revoking the marketing authorisation for TAVNEOS® (avacopan). This decision follows the recommendation made by the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) on 26 June 2026.
TAVNEOS was developed as a treatment for adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), which are the main forms of ANCA-associated vasculitis. Prior to the EC decision, TAVNEOS was authorised for use in combination with rituximab or cyclophosphamide.
TAVNEOS was developed by ChemoCentryx and is commercialised outside the US and in selected countries by VFMCRP and partners pursuant to agreements between VFMCRP and ChemoCentryx. Amgen acquired ChemoCentryx in 2022.
While we are disappointed by the decision, we respect the outcome of the regulatory process and are committed to implementing it in full. VFMCRP and CSL will work with the EMA and relevant national authorities to implement the decision and manage the discontinuation of TAVNEOS in the EU and EEA, in accordance with applicable regulatory requirements. TAVNEOS will no longer be available for prescribing in the EU and EEA. Physicians should discuss individual treatment plans with patients currently receiving TAVNEOS to determine the most suitable path forward based on clinical need.
The decision 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 prior to marketing authorisation. The EC adopted the CHMP recommendation to revoke the marketing authorisation based on the CHMP conclusion that a positive benefit-risk balance for TAVNEOS could no longer be established.
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.
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