智通财经APP获悉,3月19日,中国国家药监局药品审评中心(CDE)官网最新公示,赛诺菲(SNY.US)申报的度普利尤单抗注射液一项新适应症上市申请拟纳入优先审评,拟定适应症为大疱性类天疱疮。
3月11日,再生元(REGN.US)和赛诺菲公布了度普利尤单抗治疗中重度大疱性类天疱疮(BP)成人患者的关键性2/3期临床研究结果,该试验达到了所有主要及关键次要终点,接受度普利尤单抗治疗的患者获得持久缓解的比例是安慰剂组的5倍。目前,美国FDA已经接受度普利尤单抗用于治疗成人BP的上市申请,并授予其优先审评资格。
截图来源:CDE官网
BP是一种慢性且易复发的皮肤病,伴有潜在的2型炎症,通常发生于老年人群。其特点为剧烈瘙痒、水疱、皮肤发红及疼痛性病变。水疱和皮疹可能遍布全身,导致皮肤出血和结痂,使患者更易感染,并影响日常生活。
度普利尤单抗(dupilumab)是FDA批准的首个抗IL-4Rα抗体,由赛诺菲和再生元联合开发。它能够通过IL-4和IL-13“双靶点”的创新作用机制阻断2型炎症通路,降低2型炎症的病理性反应,从机制上治疗2型炎症相关疾病。研究表明,IL-4和IL-13是2型炎症的关键驱动因素,在多种炎症性疾病中发挥重要作用。
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