News | 26 June 2026

EMA Recommends Withdrawal of Tavneos (Avacopan) from the European Market

The European Medicines Agency (EMA) has recommended that the marketing authorisation for Tavneos (avacopan) be revoked in the European Union. Vasculitis International responds to this decision with full respect for the regulatory process — and with a clear message about what this means for patients.

What the EMA Has Decided

On 26 June 2026, EMA’s human medicines committee (CHMP) concluded its review of Tavneos and recommended that its marketing authorisation in the European Union be revoked. The ground for this recommendation is that the benefits of the medicine are no longer proven to outweigh its risks.

The review was triggered by new information raising questions about the data integrity of the ADVOCATE study — the pivotal trial on which the original marketing authorisation was based. After examining the totality of available data, the CHMP concluded that the ADVOCATE study was conducted in breach of good clinical practice (GCP) principles. Study data submitted at the time of the original authorisation were found to be incorrect and misleading, and can no longer be relied upon to demonstrate Tavneos’ effectiveness. Post-marketing data and post-hoc analyses of the ADVOCATE study were considered insufficient to fill this evidential gap.

The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable across all EU Member States. If confirmed, Tavneos will no longer be authorised in the EU.

Information for Patients

The following information is taken directly from EMA’s official communication:

• A recent review has found that the data used to support the authorisation of Tavneos cannot be relied upon to demonstrate the medicine’s effectiveness.
• EMA has therefore recommended that Tavneos should no longer be marketed in the European Union, because its benefits are no longer proven to outweigh its risks. If this recommendation is confirmed by the European Commission, Tavneos will no longer be authorised in the EU.
• No new patients should start treatment with Tavneos. If you are taking Tavneos, your doctor will discuss with you other treatment options.
• Tavneos is associated with a risk of serious liver problems (drug-induced liver injury (DILI) and vanishing bile duct syndrome (VBDS), including cases with a fatal outcome. These side effects mostly occur during the first three months of treatment with Tavneos.
• For patients treated with Tavneos for less than three months before stopping treatment, liver function should be monitored with appropriate tests at least every two weeks until three months have passed since the start of treatment.
• For patients who received Tavneos for longer than three months, liver function should be monitored every four weeks for up to six months, and then as considered necessary by the treating doctor.
• If you are taking Tavneos and have any questions, you should speak to your doctor.

Our Response: Confidence in the EMA, and Regret About What This Means for Patients

Confidence in the EMA and the CHMP

Vasculitis International has full confidence in the European Medicines Agency and its Committee for Medicinal Products for Human Use (CHMP). The EMA’s review process in this matter has been thorough, independent, and transparent. It has taken into account the views of patient and healthcare professional representatives, as well as written interventions from third parties — including input from Vasculitis International itself.

We have consistently stated, and we reaffirm today: addressing data integrity concerns and safeguarding patient access to treatment are not the same problem. They require separate answers. The EMA has engaged with both. Where the CHMP, after consulting experts, clinicians and patients, has concluded that the result of the benefit-risk analysis is negative, we of course respect and accept that outcome. That is precisely what a science-based, patient-centred regulatory system is designed to produce. We would not want it to operate differently.

What We Regret — and Why It Matters

At the same time, we cannot and will not conceal what this decision means in practice for patients living with ANCA-associated vasculitis.

We deeply regret that the only available resolution to this situation was removing the medicine from the market. That outcome is not a neutral administrative act. For vasculitis patients, it means the already narrow treatment toolbox has become narrower still. The number of therapeutic options available to vasculitis specialists was limited before; it is more limited now.

What makes this particularly significant — and what we ask the broader medical and scientific community not to overlook — is that avacopan addressed a specific and underappreciated burden: the impact of glucocorticosteroids (GCS), most commonly prednisolone, on patients’ daily lives. We now no longer have a tool specifically designed to reduce that burden.

For clinicians, reduced corticosteroid exposure is a measurable clinical outcome — expressed in laboratory values, fracture risk, and metabolic parameters. For patients, it is something far more immediate. The side effects of long-term prednisolone use — weight gain, moon face, mood changes, progressive bone loss, disrupted sleep, altered self-image — are daily lived realities that affect identity and quality of life in ways that rarely appear in clinical endpoints. Patients consistently tell us that these effects are among the aspects of their disease management they experience as most burdensome. The loss of a therapeutic option that addressed this burden is not a minor footnote. It is a real setback.

What This Strengthens Our Resolve to Pursue

This decision will strengthen us in our advocacy. The gap in the treatment landscape — particularly the absence of options that reduce glucocorticosteroid dependency — must be filled. We will advocate harder and more explicitly for research into GCS and its underestimated impact on patients’ quality of life. This is an area where the patient perspective is not adequately represented in clinical research priorities, and where Vasculitis International intends to make itself heard more forcefully.

Patients are not passive recipients of regulatory decisions. They live with the consequences. Our role is to ensure that their reality remains visible — in research design, in regulatory consultation, and in clinical practice.

About Vasculitis International

Vasculitis International (VI) is a European umbrella foundation supporting Vasculitis Patient Advocacy Groups (VPAGs) across 14+ European countries. VI engages actively with the European Medicines Agency, ERN-RITA, EULAR, and the broader vasculitis clinical and research community on behalf of patients living with ANCA-associated vasculitis and related conditions.

More information: www.vasculitisint.com