The European Commission has now formally revoked the EU marketing authorisation for Tavneos (avacopan), following the recommendation of the European Medicines Agency (EMA). This decision was made under Article 116 of Directive 2001/83/EC, which allows revocation when a medicine’s benefit–risk balance is no longer positive.
Why the EU Licence Was Revoked
The EMA concluded that
- The pivotal ADVOCATE trial — the main evidence supporting approval — is now considered unusable due to data integrity concerns. The public assessment report was adopted on 25 June 2026 and published on 6 August 2026.
- Post marketing evidence, while supportive, was judged insufficient to replace the pivotal study
- Without a reliable demonstration of benefit, the known serious liver risks (DILI and VBDS) can no longer be outweighed by a proven benefit
Issue one: data integrity. 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.
This is a regulatory and evidentiary issue, not a new safety signal. The liver risks have been known, monitored, and managed through strengthened safety protocols already in place.
UK Status
The MHRA has held its hearing but has not yet announced a decision. The weekly MHRA update published today contains no new information on Avacopan.
Key points for the UK:
- The MHRA is conducting an independent review of the reliability of the data originally submitted for licensing.
- This review is separate from safety monitoring, which continues unchanged.
- No new patients should be started on avacopan while the review is ongoing.
- Patients currently taking avacopan should not stop treatment without clinical advice.
If the MHRA ultimately revokes the licence, it will be for the same regulatory reasons as the EU — because the evidentiary foundation has been compromised — not because of new concerns about the drug’s safety profile.
Our Commitment
Vasculitis UK is working closely with:
- UKIVAS
- NHS England
- Industry partners (including CSL Vifor)
We are monitoring developments daily and preparing for all possible outcomes. UKIVAS and NHS England are already working on clinical pathways to support patients if the licence is revoked, including guidance for those currently stable on avacopan.
We will continue to provide clear, timely updates as soon as MHRA or FDA publish their decisions.