What the report says

The public assessment report was adopted on 25 June 2026 and published on 6 August 2026. If you are drafting your own material, work from it:
https://www.ema.europa.eu/en/documents/referral/tavneos-article-20-procedure-public-assessment-report_en.pd

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.

Issue two: benefit-risk. Here the EC follows the EMA saying: "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 as Vasculitis International

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 are not asking for a different decision. We are 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.

Please keep the two issues apart in your own communications as well.

Vasculitis International, Local patient organisations, individual patients and clinicians submitted written input, and patient representatives were heard during the oral explanation. The report records our input and the concerns we raised. We did not obtain the outcome we argued for, but we were part of the procedure.

What to tell your members

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. Please check with your own national authority before you tell members anything specific about stock or transitional arrangements.

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.

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 their disease can still be treated effectively.

Marketing Holder Response

Vifor Fresenius Medical Care Renal Pharma and CSL have published an open letter you may use for your own website and members 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 confirmed to us directly that support for the vasculitis community will continue. For questions at country level, CSL’s national teams and the doctors you work with are the fastest way in.

What we 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.

A detailed news item is published on vasculitisint.com.

What we ask of you

Please let us know what you are hearing from your members, especially where the national situation is unclear. Even a short note helps us see the European picture.