When a drug accompanies a rare disease, its withdrawal is never a simple matter of changing the box. For patients who had found a balance with their treatment, a new uncertainty begins. And in the case of Tavneos, the health authorities are calling for a rapid transition, but above all
no sudden stop on your own initiative.
A drug that was supposed to offer a new option to patients
Tavneos, whose active ingredient is avacopan, obtained its European authorization in 2022. It is intended for adults suffering from two rare vasculitis, granulomatosis with polyangiitis and microscopic polyangiitis. These diseases cause inflammation of small blood vessels and can particularly affect the kidneys and other organs.
The drug had raised hopes, in particular because it made it possible to reduce exposure to corticosteroids, the adverse effects of which can become significant with prolonged use.
But four years after its authorization, the balance has changed. On August 4, 2026, the European Commission withdrew the marketing authorization for Tavneos, following a recommendation from the European Medicines Agency (EMA). Its benefit-risk ratio is now considered unfavorable. In France, the ANSM announced on August 19 the recall of all lots still available. Around 600 patients were treated with Tavneos in the country.
In Japan, around twenty deaths have changed the case
The concern is not only about the effectiveness of the drug. Reports of serious liver damage have also reinforced the questions.
In spring 2026, the Kissei group, which markets Tavneos in Japan, reported a twenty deaths among patients treated since the introduction of the drug in the country in 2022in a context of serious adverse effects affecting the liver. These reports have helped fuel international concerns.
The scientific file itself was at the same time questioned. The European authorities have reassessed the data from the ADVOCATE clinical trial, which was notably used to demonstrate the effectiveness of avacopan when it was authorized.
Questions concern the integrity of certain data from this trial. However, when a drug is evaluated, the solidity of the efficacy data is essential: if the proof of its benefit becomes less robust, the entire balance between benefits and risks must be re-examined.
The EMA ultimately estimated that the profits from Tavneos “are no longer proven to outweigh the risks of treatment.
For patients, above all, do not stop alone
However, withdrawal from the market does not mean that patients must immediately stop taking their treatment. It’s actually quite the opposite.
The ANSM insists on an essential point: “Suddenly stopping Tavneos without switching to an alternative should be avoided so as not to aggravate the disease.”
Patients currently being treated should therefore contact their doctor quickly so that an alternative can be put in place. Pharmacies must no longer dispense the medication and must, in the event of a renewal request, invite the patient to contact their prescriber.
The ANSM also reminds that certain symptoms may require rapid consultation, in particular unusual fatigue, nausea, yellowing of the skin or the whites of the eyes, or even abdominal pain.
This situation reminds us of a reality that is sometimes difficult for patients to hear: the authorization of a drug is never a definitive guarantee. Its safety continues to be monitored after its marketing, when its large-scale use sometimes allows extremely rare risks to appear.
For people suffering from these vasculitis, the withdrawal of Tavneos therefore opens a delicate period. It is not simply a question of giving up treatment, but of quickly finding, with the medical team, another strategy capable of controlling a potentially serious illness.