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治疗14天,1型糖尿病风险降低59%!突破性疗法teplizumab获FDA优先审评资格

2021-01-10 医药魔方 医药魔方

1月4日,Provention Bio公司宣布已向FDA递交CD3单克隆抗体teplizumab的生物制品许可申请(BLA),用于延迟或预防高危患者的临床1型糖尿病(T1D)。FDA已授予tepliz

1月4日,Provention Bio公司宣布已向FDA递交CD3单克隆抗体teplizumab的生物制品许可申请(BLA),用于延迟或预防高危患者的临床1型糖尿病(T1D)。FDA已授予teplizumab上市申请优先审评资格,PDUFA预定审批期限为2021年7月2日。

被授予优先审评的药物意味着其在治疗、诊断或预防严重疾病安全性或有效性方面与现有疗法相比具有明显优势。因此在审查时间方面较标准审查时间(10个月)缩短4个月。

Teplizumab是一种靶向T细胞表面CD3抗原的单克隆抗体(mAb),主要通过与效应T细胞表面的CD3结合,抑制其对胰岛β-细胞的攻击,从而降低对胰岛β-细胞的破坏作用。teplizumab的Fc区域通过氨基酸修饰被设计成了Fc受体非结合(FNB)结构,从而减少了其与补体和Fc受体的结合,降低了相关毒性反应。

teplizumab作用机制

在涉及1000多例受试者的多项临床研究中,已有超过800例患者接受了teplizumab治疗。 在之前新确诊患者的研究中,teplizumab始终显示出β细胞保护功能,并能够相应地减少外源性胰岛素使用需求。

代号为At-Risk的II期临床研究共招募了76例年龄在8-49岁,具有两个及以上T1D自身抗体和异常葡萄糖代谢的"风险"患者,其中72%的受试者年龄在18岁以下。受试者随机分组接受Teplizumab或安慰剂治疗。研究结果显示,接受一个疗程(14天)治疗后,teplizumab组确诊为T1D的中位时间为48.4个月,安慰剂组为24.4个月;随访期间,teplizumab组有19人(43%)确诊T1D,安慰剂组有23人(72%),teplizumab将T1D发病风险降低了59%(HR=0.41;95% CI,0.22-0.78;P=0.006)。teplizumab组T1D年诊出率为14.9%,安慰剂组为35.9%。

FDA此前曾授予teplizumab突破性疗法资格。teplizumab治疗新确诊胰岛素依赖T1D的III期临床研究( PROTECT study)正在进行中。

Provention Bio总裁兼联合创始人Ashleigh Palmer表示,FDA接受我们的BLA代表了Provention Bio的一项重大成就。我们的使命是为患者提供首个潜在的可改变疾病进程的T1D治疗方法,从而推动有患病风险个体治疗模式的改变。我们将与FDA密切合作,配合审查,并为2021年第三季度推出teplizumab做准备。

2007年,礼来从MacroGenics公司手中以4100万美元和2亿美元里程金获得了teplizumab,但在2011年开展的一项III期试验中,teplizumab未能达到主要终点宣告临床失败。于是礼来中止并放弃teplizumab的进一步开发。2018年,Provention从MacroGenics手中拿到teplizumab开发权,并在试验中取得了积极结果。

1型糖尿病是一种自身免疫性疾病,其发病机制是免疫系统错误地攻击胰岛β细胞,导致胰岛素分泌不足,机体无法维持正常的血糖水平。对于1型糖尿病患者而言,长期注射胰岛素并配合血糖监控是必须的治疗手段。

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    2021-04-21 snf701207
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    2021-01-10 misszhang

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