European Commission officially revokes the EU authorisation for Tavneos® (avacopan)
This is the news we hoped we would not have to publish.
The European Commission has adopted its final decision and revoked the marketing authorisation for TAVNEOS® (avacopan) in the European Union and the European Economic Area.
If you are reading this from outside the EU and the EEA, this decision does not apply to you directly. The United Kingdom, Switzerland and other countries follow their own regulators, and the situation there may differ.
New and current patients
Within the EU and EEA two things are now true at the same time, and it is important to keep them apart:
- No new patients will be started on Tavneos.
- Patients who are on Tavneos today do not stop from one day to the next.
A transition period follows, and the specialist arranges it. The marketing authorisation holder will work with the EMA and with national authorities to establish the next steps in each country
The message for patients taking Tavneos®, in one sentence: do not stop or change your treatment yourself. Make an appointment, and let your specialist arrange the change. Effective treatment remains available.
What the EC Report says
The public assessment report was adopted on 25 June 2026 and published on 6 August 2026. Anyone preparing their own material should work from it: https://www.ema.europa.eu/en/documents/referral/tavneos-article-20-procedure-public-assessment-report_en.pdf
Issue one: data integrity. The report confirms what we described earlier, now on the record. After the first database lock on 5 November 2019, the sponsor saw that superiority at week 52 had not been reached. Nine patients were then re-assessed with knowledge of who had received what. At week 52 five changed status, all five in the avacopan group. None of this appeared in the dossier. The report describes it as an intentional misrepresentation affecting the primary outcome, and concludes that the study is not compliant with Good Clinical Practice and cannot be relied on. One point is new: the company had the adjudication redone independently and blind by the Duke Clinical Research Institute, and that re-adjudication also failed to show superiority.
Issue two: benefit-risk. Here the EC follows the EMA saying that “With the main study unusable and the post-marketing evidence judged insufficient to replace it, the serious liver risks are no longer outweighed by a proven benefit.” That is the legal ground for revocation, under Article 116 of Directive 2001/83/EC.
Where we stand
On the second issue we do of course follow the EMA. They hold the full dossier and the expertise to weigh it. We do not, and we do not contest their conclusion on the liver risks.
On the first issue our position has not changed: patients should not carry the cost of failures made by researchers and a sponsor. We never asked for a different decision. But we keep asking that the responsibility is placed where it belongs, and that matters for how patients are treated the next time a review like this takes place.
We ask everyone communicating about this to keep the two issues apart.
Our written input and the oral explanation are recorded in the report. We did not obtain the outcome we argued for, but we were part of the procedure.
What patients need to know
The transition is organised per country. There is no single European timetable. National authorities and the company are setting the next steps in each country. Check with your national vasculitis patient organisation, or your own national authority, before assuming anything specific about stock or transitional arrangements.
Effective treatment remains available. Tavneos was always an addition to standard treatment, not the treatment itself. The backbone of rituximab or cyclophosphamide does not change. Some patients may find their glucocorticoids are reduced more slowly than they had hoped. That is a real loss for them, and worth naming honestly. But the disease can still be treated effectively.
Nobody was given a treatment that was shown to be worse. Patients will ask whether they were harmed or misled. In every analysis, avacopan was non-inferior to the comparator. What was never shown is that it was better. That distinction is worth making clearly.
Liver monitoring continues until discontinuation is complete. The CHMP adopted a direct communication to healthcare professionals on exactly this. Monitoring does not end with the decision.
Outside the EU and the EEA, this decision does not apply directly. The United Kingdom, Switzerland and other countries follow their own regulators. Contact us if you need help finding out where your country stands.
The Marketing Holder response
The company’s response
Vifor Fresenius Medical Care Renal Pharma and CSL have published an open letter, which may be used for national websites and member communications: https://newsroom.csl.com/2026-08-06-A-further-update-on-TAVNEOS-R-avacopan-in-the-European-Union
Their Head of Global Patient Advocacy and Policy also confirmed to us directly that support for the vasculitis community will continue.
What Vasculitis International will do next
- Follow how the transition is handled in each country and share what we learn.
- Keep raising the first issue, on accountability, where it can still make a difference.
- Help with individual cases. If you need information or support for a particular patient, write to us and we will use our network.
We will keep you informed. If you need help, contact us. We will do whatever we can.