Rare disease drug Tavneos recalled in Republic of Ireland

A drug used to treat rare autoimmune diseases has been recalled from shelves in the Republic of Ireland.

Tavneos (Avacopan) is made by the US biotech firm Amgen and is sold by various partner pharmaceutical companies around the world.

In May, Kissei, which owns the rights to the drug in Japan, reported 20 deaths from more than 8,500 patients who had been treated with it in the country since 2022.

It is not clear if Tavneos was the direct cause of the deaths and Amgen has previously said "these figures include cases for which a causal relationship with the product could not be determined".

Tavneos is used to treat adults with severe and rare autoimmune diseases which cause inflammation of the blood vessels.

In July, the European Medicines Agency recommended that the drug be stripped of its market authorisation.

The European Commission endorsed that recommendation earlier this month.

The drug stopped being distributed from wholesalers in the Republic of Ireland on 11 August and the recall of any remaining stock at wholesale level was requested by the Health Products Regulatory Authority (HPRA) on Thursday.

Irish broadcaster RTÉ reports that before the European Medicines Agency's recommendation, about 60 people were treated with Tavneos.

The HPRA said the drug was only prescribed by consultants with "specialist experience in management of these conditions", and added that some had already made the decision to take patients off this drug.

The HPRA said patients currently taking the drug should not stop treatment without first consulting with their doctors.

France's medicine safety agency ANSM said the "recall of all batches" of the drug available in the country would begin on 19 August.

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK said in June that it was reviewing the benefits and risks of the drug.

The MHRA has been contacted for further comment.