France recalls rare disease drug Tavneos after deaths

France will recall the rare drug Tavneos after it was linked to 20 deaths in Japan, the country's medicine safety agency ANSM announced on Wednesday. The recall of all available batches in France will commence on August 19 following the European Commission's revocation of the drug's marketing authorization earlier this month. The European Medicines Agency recommended in July that the drug be removed from the market due to insufficient evidence supporting its benefits over its risks.

Tavneos, manufactured by U.S. biotech firm Amgen and sold by various pharmaceutical partners, treats severe and rare autoimmune diseases causing blood vessel inflammation. Kissei Pharmaceutical, which sells the drug in Japan, reported 20 deaths among users since 2022, warning doctors of severe liver dysfunction risks and urging them to stop prescribing the medicine.

The European Medicines Agency's reassessment of the data prompted the recommendation to strip the drug of its market authorization, endorsed by the European Commission. In France, Tavneos is prescribed to 600 patients, and the ANSM advises against abruptly discontinuing the drug without consulting a doctor about alternatives. The FDA offered Amgen the option of voluntarily withdrawing Tavneos in the U.S., but the company declined, leading to a procedure to determine if the drug must be pulled.