出于对 1 型糖尿病患者低血糖风险的担忧，FDA 专家组将对诺和诺德的每周胰岛素 icodec 进行审查。 FDA panel to review Novo Nordisk's weekly insulin, icodec, amid concerns of low blood sugar risk for type 1 diabetes patients.

美国食品药品监督管理局 (FDA) 内分泌和代谢药物咨询委员会将对诺和诺德公司每周使用一次的胰岛素 icodec 进行审查，因为人们担心该产品会给 1 型糖尿病患者带来更高的低血糖风险。 The FDA's Endocrinologic and Metabolic Drugs Advisory Committee is set to review Novo Nordisk's once-weekly insulin, icodec, amid concerns of a higher risk of low blood sugar for patients with type 1 diabetes. 该公司已提议更改标签并使用连续血糖监测设备来降低风险，但 FDA 工作人员指出缺乏支持这些方法的临床数据。 The company has proposed labeling changes and the use of continuous glucose monitoring devices to mitigate the risk, but the FDA staff has noted the lack of clinical data supporting these methods. FDA 不受该专家组建议的约束，但通常会遵循这些建议。 The FDA is not bound by the panel's recommendations, but usually follows them.

May 22, 2024

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