Tavneos drug withdrawn from French market due to safety risks

The drug Tavneos, used to treat rare autoimmune inflammatory vascular diseases, is being withdrawn from the French market. The French National Agency for the Safety of Medicines and Health Products (ANSM) announced the recall following a recommendation from European health authorities, citing a “risk-benefit ratio that has become unfavorable.”

In France, approximately 600 patients are prescribed the treatment. The decision follows reports of serious side effects abroad, specifically in Japan. Kissei, the distributor in Japan, reported roughly twenty deaths linked to severe liver complications among patients treated since the drug's introduction in 2022.

Tavneos was originally developed by ChemoCentryx before being acquired by the American company Amgen in 2022. The reported fatalities in Japan have raised questions regarding the integrity of the clinical studies initially provided to regulatory authorities for the drug's approval.