A critical recall of the rare autoimmune disease treatment Tavneos (generic name Avacopan) is now underway across the Republic of Ireland, following a sweeping decision by European regulators to pull the drug from the regional market.
Manufactured by U.S.-based biotechnology giant Amgen and distributed globally through a network of regional partner pharmaceutical firms, Tavneos is specifically designed to treat adults living with severe, rare autoimmune conditions that trigger dangerous inflammation of blood vessels. Until recently, it had been authorized for use across the European Union, including Ireland.
The chain of regulatory action began earlier this year, when Japanese pharmaceutical firm Kissei – which holds marketing rights to Tavneos in Japan – published safety data in May covering more than 8,500 Japanese patients treated with the drug since its 2022 launch in the country. The data showed 20 patient deaths among this treated group. To date, regulators have not confirmed whether Tavneos was the direct cause of these fatalities, and Amgen has previously pushed back on causal links, noting that “these figures include cases for which a causal relationship with the product could not be determined.”
Despite the unresolved connection, European drug regulators moved forward with restrictive action. In July, the European Medicines Agency (EMA), the EU’s top drug safety body, issued a formal recommendation to revoke Tavneos’ existing marketing authorization across the bloc. The European Commission, the EU’s executive arm, finalized and approved that recommendation earlier this August.
In line with the EU decision, Irish health regulators have moved quickly to implement the recall. Distribution of Tavneos from Irish pharmaceutical wholesalers halted on 11 August, and on Thursday, the Health Products Regulatory Authority (HPRA), Ireland’s national drug safety watchdog, issued an official order to recall all remaining wholesale stock of the drug.
According to reports from Irish public broadcaster RTÉ, around 60 patients in Ireland received Tavneos treatment before the EMA’s recommendation was issued. The HPRA clarified that the drug was only ever prescribed by specialist consultants with specific expertise in managing these rare vascular autoimmune conditions, and many of these clinicians had already begun transitioning patients to alternative treatments ahead of the formal recall.
For patients currently undergoing treatment with Tavneos, the HPRA issued a clear public advisory: do not discontinue use of the drug without first consulting your treating specialist physician, to avoid dangerous health complications from unmanaged disease.
The recall is not limited to Ireland. France’s national drug safety agency, ANSM, has announced that a full recall of all existing Tavneos batches across the country will launch on 19 August. Across the English Channel, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) confirmed back in June that it was conducting its own independent review of Tavneos’ benefits and risks, and has not yet issued a final decision. Outlets have contacted the MHRA for additional comment on the agency’s current stance following the EU’s withdrawal of authorization.