EU review puts Tavneos approval at risk

On June 26, 2026, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended that the European Union marketing authorisation for TAVNEOS (avacopan) be revoked. TAVNEOS is a treatment for adults with severe, active granulomatosis with polyangiitis or microscopic polyangiitis, used in combination with rituximab or cyclophosphamide. The recommendation marks a significant regulatory shift for the medicine within the EU market.

The CHMP’s position now moves to the European Commission, which is responsible for issuing a legally binding decision on whether TAVNEOS will remain authorised in the EU. A final decision by the Commission is expected shortly, and, if the recommendation is confirmed, TAVNEOS will no longer be authorised in the European Union.

The recommendation to revoke the authorisation stems from an Article 20 non-pharmacovigilance procedure. This type of review was initiated because of concerns about data handling in the pivotal Phase 3 ADVOCATE trial, which supported the medicine’s approval. The assessment focused on the integrity of the clinical trial data rather than on routine safety surveillance.

Following the outcome of this procedure, regulators concluded that the identified concerns warranted the withdrawal of the EU marketing authorisation. The detailed findings of the review have not been elaborated in the announcement, but the conclusion has been deemed sufficient for CHMP to support revocation.

In light of the CHMP opinion, no new patients in the European Union and European Economic Area will be treated with TAVNEOS. Patients who are currently receiving the medicine are advised to consult their treating physician to discuss their ongoing care. This reflects a transition phase while the European Commission finalises its decision.

If the Commission confirms the revocation, TAVNEOS would no longer be available as an authorised treatment option in the EU. This has implications for adults with severe, active forms of granulomatosis with polyangiitis or microscopic polyangiitis who have been using TAVNEOS alongside rituximab or cyclophosphamide.

Vifor Fresenius Medical Care Renal Pharma and CSL, which market TAVNEOS in the EU, acknowledged the CHMP recommendation and expressed disappointment with the outcome of the Article 20 procedure. They stated that they will respect the result of the regulatory process and implement it in full once the European Commission’s decision is issued.

The companies emphasised that patient care remains their highest priority. They are working with regulatory authorities, healthcare professionals and patient organisations to support a compliant and appropriate transition of treatment for affected patients, including ongoing support during the change in therapeutic approach.