.The European Medicines Agency (EMA), through the Committee for Medicinal Products for Human Use (CHMP), has recommended the revocation of the marketing authorization for Tavneos (avacopan) in the European Union, as the benefit-risk balance is no longer considered favorable.
Tavneos is authorized, in combination with rituximab or cyclophosphamide, for the treatment of adults with active and severe granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).

The reassessment of the benefit-risk balance was initiated following the emergence of new information that questioned the correctness and reliability of the data generated by the randomized clinical trial ADVOCATE on which the approval of Tavneos had been based. The CHMP concluded that the study was not conducted in accordance with good clinical practice standards governing the proper conduct of clinical trials and, therefore, that the results are inaccurate and not suitable to demonstrate the efficacy of the medicinal product; the clinical evidence collected after authorization is not considered sufficient to support the clinical benefit of the medicinal product.

In light of these conclusions, the CHMP recommends that:

• new treatments with Tavneos should not be initiated
• patients currently being treated with Tavneos:
• should be switched to appropriate alternative therapeutic options;
• should undergo careful monitoring of liver function until permanent discontinuation of treatment, considering the known risk of drug-induced liver injury (DILI) and vanishing bile duct syndrome (VBDS), including fatal cases, associated with Tavneos.

For further information, please refer to the EMA press release in English and Direct Healthcare Professional Communication containing recommendations for healthcare professionals from 16 July 2026, both available in the related links box.

The CHMP’s recommendation to revoke the marketing authorization for Tavneos was adopted with the European Commission decision n. 5725 of 4 August 2026 and is legally binding in all Member States.