Dear ANCA‑associated vasculitis community,
Further to our last update regarding TAVNEOS® (avacopan), we wanted to inform you that the European Commission (EC) has adopted a decision revoking the marketing authorisation for TAVNEOS in the European Union (EU) and European Economic Area (EEA) countries.
While we are disappointed by the decision resulting from the Article 20 procedure, we respect the outcome of the regulatory process and are committed to implementing it in full.
What happens now?
VFMCRP and CSL will work with the EMA and the relevant national authorities to determine next steps for each country in the European Union (EU) and European Economic Area (EEA). 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.
How are we supporting the community?
We want to reassure you that VFMCRP and CSL remain committed to the wider ANCA associated vasculitis (AAV) community in EU, EEA countries and globally. Patient care remains our highest priority. We are working closely with health authorities to provide information to patient communities and healthcare professionals (HCP) on next steps. Our country teams and medical information services are focused on supporting patient communities and HCPs through this transition.
For general support and further guidance about this update, please visit our contact page on https://www.csl.com/contact.
Sincerely,
Dr. Deborah Long
SVP, Medical Affairs
CSL (CSL is, with Fresenius Medical Care, a joint venture member of VFMCRP).
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.