1st September 2026
Summary
The Medicines and Healthcare products Regulatory Agency (MHRA) has completed its review of Avacopan Vifor (previously Tavneos) and concluded that the evidence supporting its efficacy is no longer sufficiently reliable to maintain a positive benefit–risk balance. As a result, the MHRA has suspended use, supply, and sale to new patients from 1 September 2026, and has announced a six‑month managed withdrawal period for existing patients. The Agency intends to revoke the UK marketing authorisation on 1 March 2027.
This follows the earlier decision by the European Commission to revoke the EU licence under Article 116 of Directive 2001/83/EC, after the pivotal ADVOCATE trial was deemed unusable due to data integrity concerns.
Why the MHRA Has Acted
The MHRA review was prompted by information raising concerns about the integrity and reliability of the pivotal ADVOCATE study, which originally supported authorisation. After detailed assessment and advice from the Commission on Human Medicines (CHM), the MHRA concluded that:
The pivotal study can no longer be relied upon to demonstrate efficacy.
The available evidence no longer supports a positive benefit–risk balance.
Regulatory action is required to protect patients while ensuring safe transition to alternative treatments.
This mirrors the EMA and European Commission’s earlier conclusion that, with the pivotal study unusable and post‑marketing evidence insufficient to replace it, the known serious liver risks (DILI and VBDS) can no longer be outweighed by a proven benefit.
This remains a regulatory and evidentiary issue, not a new safety signal.
What the MHRA Has Decided
From 1 September 2026:
- No new patients may be started on Avacopan Vifor.
- Existing patients may continue treatment during a six‑month managed withdrawal period.
Clinicians are asked to review current patients promptly and plan safe transition to alternative therapies.
The MHRA intends to revoke the UK marketing authorisation on 1 March 2027.
The marketing authorisation holder has guaranteed supply for existing patients throughout the transition period.
Patients should not stop treatment without specialist advice.
Context: EU and International Regulatory Decisions
The MHRA decision follows the European Commission’s revocation of the EU licence in August 2026, after the EMA determined that:
The pivotal ADVOCATE trial was non‑compliant with Good Clinical Practice and unusable due to data integrity failures.
Independent re‑adjudication by the Duke Clinical Research Institute also failed to confirm superiority at week 52.
Post‑marketing evidence, while supportive, was insufficient to replace the pivotal study.
Without reliable evidence of benefit, serious liver risks could not be outweighed by a proven benefit.
The U.S. FDA has also proposed withdrawal of approval, citing unproven effectiveness and false statements in the original application.
Implications for Patients and Clinicians in the UK
Do not stop Avacopan without clinical advice.
Clinicians should review all current patients and plan transitions during the managed withdrawal period.
No new patients should be initiated on Avacopan.
This is a completed regulatory action, not an emerging safety alert.
Our Commitment
Vasculitis UK is working closely with:
- UKIVAS
- NHS England
- Industry partners (including CSL Vifor)
We are supporting preparations for clinical pathways to ensure patients are safely transitioned to alternative treatments. We will continue to provide clear, timely updates as further information becomes available, including any developments from the MHRA or FDA.
You can read the MHRA press release here.