France is set to recall the rare-disease medicine Tavneos after 20 deaths were reported among patients taking the drug in Japan, according to the country’s medicine safety agency.
The recall of all Tavneos batches currently available in France will begin on August 19, the French National Agency for the Safety of Medicines and Health Products (ANSM) said in a statement.
Earlier this month, the European Commission revoked Tavneos’ marketing authorisation after concluding that the available evidence no longer showed that the medicine’s benefits outweighed its potential risks.
Tavneos is produced by US biotechnology company Amgen and is marketed through different pharmaceutical partners in countries around the world.
The medicine is prescribed to adults suffering from severe and rare autoimmune diseases that cause inflammation of the blood vessels.
20 Deaths Reported in Japan
Kissei Pharmaceutical, which markets Tavneos in Japan, reported in May that 20 deaths had been recorded among people who had taken the drug since 2022.
The Japanese company subsequently alerted doctors to the possibility of severe liver dysfunction and called on them to stop prescribing Tavneos.
However, Kissei and Amgen both stressed that the reported deaths also included cases where no direct causal connection to the medicine could be confirmed.
The reports nevertheless prompted concerns over the robustness of the clinical study submitted to regulators when Tavneos was being assessed for marketing authorisation.
European Review Led to Withdrawal
The European Medicines Agency (EMA) reviewed the available evidence following the safety concerns. In July, the agency recommended that Tavneos’ marketing authorisation in Europe be withdrawn.
The European Commission approved that recommendation earlier this month, leading to the withdrawal of the medicine from the European market.
In France, approximately 600 patients are currently receiving Tavneos, according to the ANSM.
The French agency has warned patients not to stop taking the medicine suddenly without first moving to another appropriate treatment. An abrupt interruption could lead to a worsening of their medical condition.
Patients taking Tavneos have therefore been advised to speak with their doctors about suitable alternative treatments.
Tavneos Remains Under Review in the US
The situation is also being examined in the United States. The US Food and Drug Administration (FDA) gave Amgen the option of voluntarily removing Tavneos from the US market.
Amgen declined to do so, and a regulatory procedure is now underway to determine whether the company will ultimately be required to withdraw the drug in the United States.