Switzerland monitors Japanese concerns over Tavneos drug
Switzerland’s drugs regulator Swissmedic is closely monitoring international developments around the drug Tavneos following warnings from Japan about several deaths.
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Switzerland monitors Japanese concerns over Tavneos drug
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The Japanese pharmaceutical company Kissei Pharmaceutical has warned doctors against prescribing Tavneos, a drug developed by the American biotech company Amgen to treat rare autoimmune diseases, to new patients. Since the drug’s market launch in 2021, 20 people have died after taking it.
The Japanese company warned physicians of the risk of severe liver dysfunction and urged them to review whether ongoing treatments should be continued.
Although no deaths have been recorded in the United States, the Food and Drug Administration (FDA) is proposing to revoke the drug’s approval, while the European Medicines Agency (EMA) has launched a review. Both agencies have expressed concerns regarding data falsification and other issues.
The Swiss Agency for Therapeutic Products, Swissmedic, told the Keystone-SDA news agency that it closely monitors international developments concerning every drug approved in Switzerland and is in contact with foreign drug regulatory authorities. This also applies to Tavneos/Avacopan, which has been approved in Switzerland since 2022.
Swissmedic also continuously analyses available information as part of its market surveillance and drug safety monitoring.
Currently, however, there is no formal, independent procedure underway in Switzerland to withdraw or suspend the approval of Tavneos. Therefore, the drug remains authorised in Switzerland, according to Swissmedic.
Adapted from German by AI/mga
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