林业发展局正在审查Sanofi关于批准Tzield为年龄小至1岁的儿童提供早期1型糖尿病的请求。 The FDA is reviewing Sanofi’s request to approve Tzield for children as young as one with early type 1 diabetes.

林业发展局对Sanofi申请进行优先审查,将第1型糖尿病治疗Tzield扩大适用于患有第2阶段疾病的一岁以下儿童。 The FDA has granted priority review to Sanofi’s application to expand Tzield, a type 1 diabetes treatment, to children as young as one year old with stage 2 disease. Tzield目前为8岁及8岁以上的人核准,目的是推迟进入依赖胰岛素的第3阶段糖尿病。 Currently approved for ages eight and older, Tzield aims to delay progression to insulin-dependent stage 3 diabetes. 这项请求得到PETITE-T1D第4阶段研究提供的为期一年的临时数据的支持,该研究显示幼儿的安全和药用动力学。 The request is backed by one-year interim data from the PETITE-T1D phase 4 study showing safety and pharmacokinetics in young children. 如果得到批准,这将是该年龄组首例疾病改变疗法。 If approved, it would be the first disease-modifying therapy for this age group. 预计FDA的决定将于2026年4月29日之前出台. The FDA’s decision is expected by April 29, 2026.