The European Medicines Agency (EMA) has started a review of the medicine Tavneos (avacopan). Tavneos is used in adults with rare forms of ANCA-associated vasculitis, specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

We recognise that news about a regulatory review of a medicine can raise questions or concerns among patients. We therefore want to clearly explain what this review involves — and, just as importantly, what it does not mean.

What kind of review is this?

This review is not a safety (pharmacovigilance) procedure. There are no new safety signals or newly identified side effects that have triggered this process.

The current review is a so called Article 20 non-pharmacovigilance procedure, initiated at the request of the European Commission. This type of procedure is used when questions arise about the scientific basis or robustness of the data that supported the original approval of a medicine.

In the case of Tavneos, concerns have been raised about how certain data from the main clinical study were collected, analysed, or reported. As a result, the EMA has been asked to re-examine all available evidence to confirm whether the original conclusions remain valid.

This distinction is important and reassuring: the focus is on data integrity and regulatory decision-making, not on newly discovered risks to patients.

Why is this being done?

In Europe, medicines continue to be monitored even after approval. When new information raises questions about the evidence supporting a regulatory decision, authorities are required to review this transparently and thoroughly.

Such a review reflects the strength and rigor of the European regulatory system, ensuring that approvals remain based on the best and most reliable scientific evidence available.

What happens next?

The EMA will reassess whether the benefit–risk balance of Tavneos remains favourable. Possible outcomes may include:

• maintaining the current approval,
• introducing clarifications or additional conditions,
• or making other regulatory adjustments if necessary.

At this stage, no conclusions have been reached, and there are no changes to the current use of Tavneos.

What does this mean for patients?

For patients currently taking Tavneos, the key messages are:

• Do not stop treatment without consulting your treating physician.
• There is no indication that Tavneos has been deemed unsafe.
• This review is a careful scientific reassessment, not an emergency measure.

Patients who have questions or concerns are encouraged to discuss these with their healthcare provider, who can provide advice tailored to their individual situation.

Vasculitis International’s role

Vasculitis International is closely monitoring this review and remains attentive to updates from regulatory authorities. We will inform our member organisations and the wider patient community as soon as new, relevant information becomes available.

Our commitment remains unchanged: to provide patient representatives and people living with vasculitis with clear, balanced, and trustworthy information, supporting informed decision-making in partnership with healthcare professionals.