A vasculitis medicine has been suspended. What patients should do

What happened

On 1 September 2026, the UK's medicines regulator suspended a medicine called Avacopan Vifor. Its active ingredient is avacopan. You may have seen it under its former brand name, Tavneos. The regulator is the Medicines and Healthcare products Regulatory Agency, usually shortened to the MHRA. It is the body that decides which medicines can be sold and used in the UK. Avacopan treats two rare conditions: granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). Doctors often group these together as ANCA-associated vasculitis. In these conditions the immune system attacks the body's own small blood vessels by mistake. That can damage the kidneys and lungs, and it can be very serious. Avacopan is given to adults alongside one of two other medicines, either rituximab or cyclophosphamide. The suspension has two parts. The first is about new patients. From 1 September 2026, doctors must not start anyone new on this medicine. The second is about people already taking it. Supply carries on for them during a six-month "managed withdrawal" period, so they can be moved safely onto a different treatment rather than cut off suddenly. The MHRA intends to withdraw the UK licence completely on 1 March 2027. The reason is unusual. It is not that a frightening new side effect turned up in UK patients last week. It is that the main study used to approve the medicine is no longer trusted. In the MHRA's words, the study "can no longer be relied upon to demonstrate the efficacy of Avacopan Vifor." One line matters more than any other here, and the MHRA said it plainly. If you are taking this medicine, do not stop it on your own. Speak to your specialist team first.

Why this matters

This affects a small number of people, but it affects them a great deal. Vasculitis is rare, and people treated with avacopan are usually those who have been seriously unwell. Their treatment is carefully balanced and is managed by hospital specialists rather than a GP. Changing it is not a small admin job. It needs a proper conversation, and it needs to happen soon. That is why the MHRA allowed six months rather than stopping supply overnight. It also matters because of how the decision was reached. Medicines are approved on evidence. When that evidence turns out to be unreliable, regulators are supposed to act, even when doing so is awkward and expensive. The UK is not acting alone. The European Commission revoked the medicine's authorisation across the EU and EEA on 6 August 2026, following a recommendation from the European Medicines Agency's expert committee on 26 June 2026. In the United States, the Food and Drug Administration has run its own investigation and has moved to withdraw the drug too. Three separate regulators, looking at the same evidence, reached the same conclusion. That agreement is worth something. There is a harder point, and it is fair to say out loud. Some patients and their doctors believed this medicine helped them. Being told the proof was flawed is upsetting, and it can shake your confidence in the whole system. It is reasonable to feel let down. It is also reasonable to take some reassurance from the fact that the problem was found, investigated openly and acted on.

What the evidence actually says

It is worth being precise about what went wrong, because the details matter. The study in question is called ADVOCATE. It was the pivotal trial, meaning the main piece of evidence used to approve avacopan. It was published in the New England Journal of Medicine, one of the most respected medical journals in the world. On 29 June 2026, that journal retracted the paper. A retraction means the journal formally withdraws a study from the scientific record. Reporting on it noted this was the first time in the journal's history of more than 200 years that it had retracted a registrational study, meaning one used as the basis for a medicine's approval. The retraction was requested by the two academic authors, Professor David Jayne and Professor Peter Merkel. They asked for it after learning that the main outcome for nine patients had been re-assessed after the trial database was locked and after the trial had been unblinded. Unblinding is the point at which researchers find out who received the drug and who did not. Re-judging results after that point opens the door to bias. The authors said this happened without their knowledge, and it came to light during the FDA's investigation. According to the FDA's account, an early analysis of the trial's main measure did not reach statistical significance. In other words, on the first look, the drug had not been shown to work. Unblinded company staff then selected participants for re-adjudication. Five patients on avacopan were reclassified from "not in sustained remission" to "sustained remission". After those changes, the result did reach significance. There is a second, separate issue. In March 2026, the FDA issued a drug safety communication after a review of real-world reports identified 76 cases of serious drug-induced liver injury linked to avacopan, including deaths from a condition called vanishing bile duct syndrome. Here is the honest summary. The retraction is about whether the medicine was ever properly shown to work. It is not, by itself, proof that it harmed most people who took it. But set an unproven benefit next to a real safety signal, and the balance of benefit and risk no longer holds up. That is the judgement all three regulators have made. It is just as important to say what this does not mean. It does not mean everyone who took avacopan has been harmed. It does not mean other vasculitis treatments are in doubt. Rituximab, cyclophosphamide and steroid-based treatments are not affected.

Qurexa perspective

We should be straight about our role here. Avacopan is a specialist hospital medicine. It does not arrive on a routine community repeat prescription, and it is not a medicine Qurexa supplies or advises on. If you take it, the people who can answer your questions are your vasculitis or kidney team at the hospital. Nobody at a delivery service, us included, should be guiding that decision. What we do see, again and again, is what happens around a treatment change. When one medicine stops and another starts, the rest of a person's prescription list often shifts too. Steroid doses get adjusted. Tablets protecting the stomach or bones get added or changed. This is exactly when things slip through the cracks: an old item still ordered out of habit, or a new one missing from the repeat list. So the useful thing we can offer is simple. If your hospital team changes your treatment in the coming weeks, tell your GP practice and your pharmacy, and check your repeat list reflects the change before your next order goes in. Whether that pharmacy is us or anyone else, that one check prevents most of the problems we see.

Practical advice

If you or someone you look after takes avacopan, here is what to do. Do not stop taking it on your own. Stopping a vasculitis treatment suddenly and without a plan carries its own risks. The MHRA has been explicit about this. Expect to hear from your specialist team. Healthcare professionals have been told to review patients already on the medicine at the earliest opportunity. If a few weeks pass and nobody has been in touch, do not simply wait. Ring the specialist nurse or the consultant's secretary and ask to be reviewed. There is a six-month window, and it is better to use the start of it than the end. Write your questions down before the appointment. Good ones include: what will I take instead, how quickly will we make the change, what should I watch out for, and what happens if my symptoms come back? Know the warning signs of liver problems, given the safety signal reported. These include yellowing of the skin or the whites of the eyes, dark urine, pale stools, unusual itching, feeling sick, unusual tiredness, or pain in the upper right side of your tummy. If you notice these, seek medical advice urgently. Keep taking your other medicines as prescribed unless told otherwise. This decision is about one medicine only. Report any side effect through the MHRA's Yellow Card scheme at yellowcard.mhra.gov.uk. Patients can report directly, and those reports are part of how problems like the liver signal get spotted. Be careful what you read. A story like this attracts noise online, including people selling alternatives. Stick to your specialist team, the MHRA and the NHS.

What to know

The short version. The MHRA suspended Avacopan Vifor (avacopan, formerly Tavneos) for new patients on 1 September 2026, and intends to revoke its UK licence on 1 March 2027. People already taking it can continue during a six-month managed withdrawal while they are moved to another treatment. The reason is that the main trial behind its approval, ADVOCATE, was retracted after outcomes for nine patients were re-assessed following database lock and unblinding. There is a separate safety signal: the FDA reported 76 cases of serious liver injury linked to the drug in March 2026. The EU revoked the medicine's authorisation on 6 August 2026, and the FDA has moved to withdraw it in the US. If you take it, do not stop on your own. Contact your specialist team, and chase them if you have not heard. Other vasculitis treatments are not affected. Sources: GOV.UK (MHRA), "MHRA concludes review of Avacopan Vifor following reassessment of benefit-risk balance", 1 September 2026, https://www.gov.uk/government/news/mhra-concludes-review-of-avacopan-vifor-following-reassessment-of-benefit-risk-balance; New England Journal of Medicine, "RETRACTED: Avacopan for the Treatment of ANCA-Associated Vasculitis", retraction published 29 June 2026, https://www.nejm.org/doi/full/10.1056/NEJMoa2023386; European Medicines Agency, "EMA recommends revoking marketing authorisation for Tavneos", 26 June 2026, https://www.ema.europa.eu/en/news/ema-recommends-revoking-marketing-authorisation-tavneos; CSL Vifor Newsroom, "European Commission (EC) adopts decision to revoke marketing authorisation for TAVNEOS (avacopan) in the European Union and European Economic Area countries", 6 August 2026, https://newsroom.csl.com/2026-08-06-European-Commission-EC-adopts-decision-to-revoke-marketing-authorisation-for-TAVNEOS-R-avacopan-in-the-European-Union-and-European-Economic-Area-countries; Healio Rheumatology, "New England Journal of Medicine retracts avacopan study used by FDA to assess efficacy", 10 July 2026, https://www.healio.com/news/rheumatology/20260710/new-england-journal-of-medicine-retracts-avacopan-study-used-by-fda-to-assess-efficacy; The Lancet Rheumatology, "The end for avacopan", 2026, https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(26)00225-0/fulltext This article is for general information and does not replace advice from a doctor, pharmacist or other qualified healthcare professional. If you are taking avacopan, do not stop or change your treatment without speaking to your specialist team first.