The HPRA has requested a wholesale recall of Tavneos (avacopan) in the Republic of Ireland after the EMA recommended revoking the drug’s market authorisation. Japan’s Kissei reported 20 deaths among more than 8,500 treated patients, though no causal link has been established. National agencies including the ANSM and MHRA are reviewing the medicine; patients are advised not to stop treatment without consulting their doctor.
Tavneos (Avacopan) Recalled In Republic Of Ireland After European Regulators Recommend Withdrawal
Tavneos is used to treat adults with severe and rare autoimmune diseases which cause inflammation of the blood vessels (stock image) [Getty Images]
The Health Products Regulatory Authority (HPRA) in the Republic of Ireland has requested the recall of remaining wholesale stock of Tavneos (avacopan) after European regulators recommended the drug's withdrawal from the market.
What Happened
Tavneos, an oral medication produced by Amgen and distributed globally through partner companies, is used to treat adults with rare autoimmune diseases that cause inflammation of blood vessels (vasculitis). In July, the European Medicines Agency (EMA) recommended that Tavneos have its market authorisation revoked. The European Commission endorsed that recommendation earlier this month.
Safety Reports And Regulatory Actions
In May, Kissei — the company that holds rights to Tavneos in Japan — reported 20 deaths among more than 8,500 patients treated with the drug in Japan since 2022. It has not been established that Tavneos directly caused those deaths; Amgen has said these reports include cases for which a causal relationship could not be determined.
Following the EMA recommendation, the HPRA stopped wholesale distribution of Tavneos in Ireland on 11 August and requested a wholesale-level recall on Thursday. Irish broadcaster RTÉ reported that roughly 60 patients in the Republic of Ireland had received Tavneos prior to the EMA decision.
Guidance For Patients And Clinicians
The HPRA emphasised that Tavneos was prescribed only by consultants with specialist experience in managing these conditions and noted some clinicians had already switched patients off the drug. Patients currently taking Tavneos are advised not to stop treatment without first consulting their treating doctor.
Other National Responses
France's medicines regulator (ANSM) said it would begin recalling all available batches in the country from 19 August. The UK Medicines and Healthcare products Regulatory Agency (MHRA) said in June it was reviewing Tavneos’ benefits and risks; the MHRA has been contacted for further comment.
Summary: European regulators have moved to withdraw Tavneos while national agencies coordinate recalls and reviews. Patients should consult their prescribers before making any changes to treatment.
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