France recalls rare disease drug Tavneos after deaths
France is recalling the autoimmune drug Tavneos following its link to 20 deaths in Japan and the revocation of its marketing authorization by the European Commission. While the manufacturer Amgen disputes the causal link, regulators have determined the drug's risks outweigh its benefits.
Why it matters
The recall underscores the critical role of international regulatory oversight in pharmaceutical safety and the potential risks associated with rare disease treatments.
A drug called Tavneos used to treat rare autoimmune diseases will be pulled from the shelves in France, the country's medicine watchdog said Wednesday, after it was linked to 20 deaths in Japan.
"The recall of all batches available in France will begin on August 19," France's medicine safety agency ANSM said in a statement.
The agency noted that the European Commission revoked the drug's marketing authorisation earlier this month because "the benefits are no longer proven to outweigh its risks".
Tavneos is made by the U.S. biotech firm Amgen and is sold by different partner pharmaceutical companies around the world.
It is used to treat adults with severe and rare autoimmune diseases which cause inflammation of the blood vessels.
Kissei Pharmaceutical, which sells the drug in Japan, said in May that 20 deaths had been reported among people using the it since 2022.
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