A medication designed to treat rare autoimmune diseases has been withdrawn from distribution in the Republic of Ireland following a regulatory decision to revoke its market approval.
Tavneos, the brand name for avacopan, is manufactured by US-based biotech company Amgen and distributed through various pharmaceutical partners globally. The drug targets adults living with severe, rare autoimmune conditions characterised by inflammation affecting blood vessel walls.
The sequence of events leading to the recall began in May when Kissei Pharmaceutical, which holds distribution rights in Japan, disclosed that 20 deaths had been recorded among more than 8,500 patients treated with the medication since 2022. Amgen subsequently clarified that
these figures include cases for which a causal relationship with the product could not be determined, indicating uncertainty about whether Tavneos directly caused all reported fatalities.
In July, the European Medicines Agency (EMA) recommended that Tavneos be stripped of its market authorisation across European Union member states. The European Commission formally endorsed this recommendation in early August, triggering the withdrawal process.
How did the recall unfold in Ireland?
Distribution of Tavneos from pharmaceutical wholesalers in the Republic of Ireland ceased on 11 August. On Thursday of the following week, the Health Products Regulatory Authority (HPRA), Ireland's medicines regulator, formally requested the recall of all remaining stock held at wholesale level.
Prior to the EMA's recommendation, approximately 60 people in Ireland had received treatment with Tavneos, according to reporting from a national broadcaster. The HPRA emphasised that the drug had only been prescribed by consultants with specialist expertise in managing these particular conditions, and noted that some specialists had already begun transitioning their patients away from the medication independently.
What guidance has been issued to patients?
The HPRA has advised patients currently taking Tavneos not to discontinue treatment without first seeking guidance from their healthcare provider. This precaution reflects the serious nature of the conditions being treated and the need for medical supervision during any transition to alternative therapies.
What is happening in other countries?
France's national medicines safety agency, ANSM, announced that the recall of all batches of Tavneos available in France would commence on 19 August. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) initiated a review of the drug's benefits and risks in June and has not yet announced a final decision on its status.
The regulatory actions across multiple European jurisdictions reflect a coordinated response to safety concerns, though the exact causal link between the medication and reported adverse outcomes remains under investigation.
Key Facts
- Tavneos (avacopan) treats rare autoimmune diseases causing blood vessel inflammation in adults
- The European Medicines Agency recommended withdrawal of market authorisation in July, endorsed by the European Commission in August
- Approximately 60 people in Ireland had been treated with the drug before the regulatory decision
- Twenty deaths were reported among 8,500 Japanese patients since 2022, though causality has not been established in all cases
- Patients currently on the medication should consult their doctors before stopping treatment
