MHRA review of avacopan: what healthcare professionals need to know

On 5th June 2026, the MHRA announced a review of the benefits and risks of avacopan in ANCA-associated vasculitis (AAV). The review has been triggered by concerns about the integrity and reliability of data from the ADVOCATE trial – the pivotal clinical trial that underpinned the drug’s licence approval.

Avacopan (Tavneos) is a complement C5a receptor inhibitor licensed as a steroid-sparing agent for adults with severe active GPA or MPA, used in combination with rituximab or cyclophosphamide. It was incorporated into the 2025 BSR management recommendations and has been an important option for reducing glucocorticoid exposure in eligible patients.

What this means in practice

The MHRA review is ongoing, and no regulatory action has been taken yet. In the meantime:

For healthcare professionals: carefully consider the individual benefits and risks for each patient currently receiving avacopan or being considered for it. This is particularly relevant given that the evidence base supporting its use is now under scrutiny.

For patients: do not stop taking avacopan without first consulting your healthcare professional. Abrupt discontinuation could leave AAV inadequately treated, and any change in management needs to be planned carefully with the clinical team.

Looking ahead

The MHRA will communicate the outcome of its review – including any new guidance for UK clinicians and patients – once it is complete. Until then, clinicians should monitor for further updates and apply careful individual risk-benefit assessment when making prescribing decisions.