Tavneos Marketing Authorization Revoked Amid Safety Concerns

The European Commission has revoked the marketing authorization for Tavneos, a rare disease drug made by Amgen, after determining that its benefits no longer outweigh its risks.

The decision was based on data from Japan, where Kissei Pharmaceutical reported 20 deaths among patients using the medication since 2022. The company warned of 'the risk of severe liver dysfunction' and advised doctors to stop prescribing it.

Amgen refused the option to voluntarily withdraw Tavneos from shelves in the United States, leading to a procedure to determine whether they will be forced to pull the drug.

The ANSM, France's medicine safety agency, has initiated a recall of all batches available in France and advises patients to consult their doctors about alternatives. Abruptly stopping Tavneos could worsen the condition.