欧盟批准萨诺菲(Sanofi)的Teizeild(Teizeild)将高风险病人的1型糖尿病延迟治疗, The EU approved Sanofi’s Teizeild to delay type 1 diabetes in high-risk patients, based on strong trial results.

欧洲联盟已经批准Sanofi的Teizeild(teplizumab)推迟8岁及8岁以上患有以自体和异常葡萄糖水平为定义的2级疾病的患者进入1型糖尿病症状。 The European Union has approved Teizeild (teplizumab) by Sanofi to delay progression to symptomatic type 1 diabetes in patients aged eight and older with stage 2 disease, defined by autoantibodies and abnormal glucose levels. 根据TN-10试验,单次14天疗程延迟了需要胰岛素的第三阶段的发病时间,平均为48. 4个月,而安慰剂患者则为24. 4个月,在研究结束时,57%的治疗患者仍处于第二阶段. Based on the TN-10 trial, a single 14-day course delayed stage 3 onset—requiring insulin—by a median of 48.4 months versus 24.4 months in placebo, with 57% of treated patients remaining in stage 2 at study end. 该药物保留了乙型细胞功能,是欧盟为这一疾病批准的第一种疾病缓解疗法。 The drug, which preserves beta cell function, is the first disease-modifying therapy approved in the EU for this condition. 常见副作用是暂时性淋巴质和皮疹。 Common side effects were temporary lymphopenia and rash. 它已在美国、联合王国、加拿大和中国获得批准,美国正在进行优先审查,供年幼儿童使用。 It is already approved in the U.S., UK, Canada, and China, with U.S. priority review ongoing for use in children as young as one.