On June 26, 2026, the European Medicines Agency (EMA) took a rare decision: its Committee for Medicinal Products for Human Use (CHMP) recommended the revocation of the marketing authorization of a treatment for two serious vasculitides, granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). This committee considers that the benefits of this medication no longer clearly outweigh its risks, in particular severe liver damage.
The medicine in question is Tavneos (avacopan), used in adults in combination with rituximab or cyclophosphamide to treat these rare blood vessel diseases. If the European Commission confirms the CHMP opinion, Tavneos will no longer be authorized in the European Union. In the immediate future, the EMA is asking to no longer initiate new treatments and to prepare for the switch of patients already on Tavneos to other options. For caregivers and patients alike, this is possible
withdrawal asks very concrete questions.
What the revocation of Tavneos’ marketing authorization would change in practice
The procedure was triggered at the request of the European Commission, on the basis of Article 20 of Regulation (EC) No 726/2004. After reviewing all available data, the CHMP judged that the benefits of Tavneos are no longer proven to outweigh its risks. If the decision to revoke the marketing authorization is confirmed, the medicine will have to be withdrawn from all Member States of the European Union.
In France, the National Agency for the Safety of Medicines and Health Products (ANSM) already applies this opinion. She asks doctors to no longer prescribe Tavneos, to contact treated patients quickly and to organize an alternative. Liver function should be checked often, every two weeks until three months have passed since the start of treatment, then every four weeks up to six months for longer treatments.
ADVOCATE trial and liver risks: reasons for questioning
Tavneos’ approval was based on the ADVOCATE trial, which included 331 patients with GPA or MPA followed for 52 weeks. After re-examination, the CHMP considers that this trial violated good clinical practice and that the data submitted was incorrect and misleading, to the point that it could no longer be used as proof of effectiveness.
On the safety side, Tavneos is associated with serious liver damage, including drug-induced liver injury (DILI) and disappearing bile duct syndrome (VBDS), which can be fatal. According to the data, 20 deaths were reported in Japan and 76 cases to the US Food and Drug Administration, mostly during the first three months of treatment. These signals weighed in the new risk-benefit balance.
Patients on Tavneos: immediate instructions and next steps
For patients, the ANSM recommends not stopping Tavneos alone, but quickly contacting the specialist doctor to organize another treatment while continuing to monitor the liver. The EMA is preparing an information letter to healthcare professionals and the final decision from the European Commission is expected in the coming weeks.