赛诺菲/再生元Dupixent获FDA突破性疗法认定

2020-09-15 亿欧 亿欧

据外媒报道,昨日,美国FDA授予了赛诺菲/再生元Dupixent(dupilumab,度普利尤单抗)突破性治疗指定,用于治疗12岁及以上的嗜酸性粒细胞性食管炎(EoE)患者。此次认定基于对EoE患者进

据外媒报道,昨日,美国FDA授予了赛诺菲/再生元Dupixent(dupilumab,度普利尤单抗)突破性治疗指定,用于治疗12岁及以上的嗜酸性粒细胞性食管炎(EoE)患者。此次认定基于对EoE患者进行的3期临床试验Part A的积极结果。早在2017年,Dupixent还被授予孤儿药称号,用于潜在的EoE治疗。

Dupixent是一种全人类单克隆抗体,可抑制白细胞介素-4(IL-4)和白细胞介素-13(IL-13)蛋白的信号传导。过往临床试验的数据显示,IL-4和IL-13是2型炎症的关键驱动因素,在哮喘、CRSwNP和特应性皮炎(AD)中起主要作用。

目前,该药物在美国已被批准用于治疗6岁及以上的中重度AD患者,而在美国以外的国家,包括欧盟和日本,Dupixent则被批准用于中重度AD、哮喘以及某些患有严重CRSwNP的成年患者治疗。今年6月,NMPA批准了该药物用于治疗成人中重度AD。

到目前为止,Dupixent已经在超过10000例患者中进行了50项临床试验,研究对象是由2型炎症引起的各种慢性疾病。

而除了目前批准的适应症外,赛诺菲和再生元两家公司正在联合研究由2型炎症或其他过敏反应引起的广泛疾病,包括儿童哮喘(6-11岁,Ⅲ期临床)、儿童特应性皮炎(6个月至5岁,Ⅲ期临床)、EoE(Ⅲ期临床)、慢性阻塞性肺疾病(Ⅲ期临床)、大疱性类天疱疮(Ⅲ期临床)、结节性痒疹(Ⅲ期临床)、慢性自发性荨麻疹(Ⅲ期临床)、食物和环境过敏(Ⅱ期临床)。

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