Dear ANCA‑associated vasculitis community,
We are writing to share an important update on TAVNEOS® (avacopan) in the European Union (EU).
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended the revocation of the EU marketing authorisation for TAVNEOS.
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.
What are we doing to support the community?
Patient care remains our highest priority. If you are living with ANCA-associated vasculitis (AAV), or supporting someone who is, this news may be difficult and naturally raises questions about ongoing treatment.
For people currently receiving TAVNEOS, the most important next step is to speak with their treating physician. They are best placed to review each patient’s situation in the context of clinical needs and regulatory guidance.
We deeply value our well-established partnership with the vasculitis community and will continue to provide further updates to ensure people living with AAV and their healthcare providers are informed and supported through this transition. We remain focused on bringing innovative treatment options to patients living with rare diseases.
Why is this happening?
This regulatory action is the result of a regulatory non-pharmacovigilance referral procedure initiated by the EMA, due to concerns relating to data handling in the pivotal Phase 3 ADVOCATE trial that supported TAVNEOS approval.
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.
While we recognise the important role TAVNEOS has played for people living with AAV, we are committed to respecting and implementing the CHMP’s recommendation.
For general support and further guidance about this update, please reach out to CSL Medical Information: medinfo@viforpharma.com. For further information, please visit our contact page on https://www.csl.com/contact.
Sincerely,
Dr. Deborah Long
SVP, Medical Affairs
CSL
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.