Vasculitis International has published its position statement on the ongoing regulatory review of TAVNEOS® (avacopan) — and warns that two very different questions must not be treated as one.

One medicine. Two questions.

On data integrity: We view the manipulation of clinical trial data as a very serious offense. The reliability of clinical trial data is the foundation on which medicine rests. Where that foundation is compromised, those responsible must be held to account — clearly and visibly, and regardless of the therapeutic value of the product involved.

On benefit and risk: This is a separate question — and it deserves a separate answer. Four years of real-world use have shown that TAVNEOS offers meaningful benefit to patients with GPA and MPA, not least because it reduces their dependence on long-term corticosteroids — a burden that patients consistently experience as far heavier than clinicians tend to recognise. That evidence exists independently of the disputed trial data and must be weighed on its own merits.

Our concern: When these two questions are treated as one, it is patients who pay the price — for something they had no part in. Withdrawing a treatment is not a neutral act. It is a decision with real consequences for people who depend on a medicine that works, in a disease where treatment options are already limited.

We urge the EMA to weigh both questions fully, fairly, and independently — and to ensure that real-world patient experience is part of that assessment.

This article is a plain-language summary of our full position statement.