France recalls rare disease drug Tavneos after deaths
Tavneos is made by the U.S. biotech firm Amgen and is sold by different partner pharmaceutical companies around the world
France has recalled the rare drug Tavneos after it was linked to 20 deaths in Japan, according to the country's medicine watchdog. The drug, made by the U.S. biotech company Amgen, is used to treat severe autoimmune diseases in adults. The European Commission revoked the drug's marketing authorization earlier this month due to its risks outweighing the benefits.
Tavneos is prescribed to 600 patients in France. The European Medicines Agency recommended the drug be removed from the market in July, which the European Commission endorsed. The drug has been available in France since 2022, and warnings about severe liver dysfunction were issued by Kissei Pharmaceutical, the Japanese company selling Tavneos.
Both Kissei and Amgen stated that some deaths might not be directly linked to the drug. The FDA offered Amgen the chance to voluntarily withdraw Tavneos in the U.S., but the company declined.
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