智通财经APP获悉,11月12日,CDE官网公示,强生(JNJ.US)尼卡利单抗注射液拟被纳入优先审评,适用于治疗自身抗体阳性的全身型重症肌无力(gMG)成人患者和青少年患者(大于12岁)。尼卡利单抗(Nipocalimab)是强生通过约65亿美元收购Momenta Pharmaceuticals获得的一款在研FcRn抗体。今年8月,该药已在美国申报上市,用于重症肌无力。本次被CDE纳入拟优先审评意味着该药也有望很快在中国报上市。
重症肌无力(MG)是一种自身抗体疾病。MG最初的疾病表现通常为眼部,但约85%的患者会出现眼肌以外的症状,发展为全身型重症肌无力(gMG)。在中国,gMG已被纳入《第一批罕见病目录》。
今年10月,强生还公布了尼卡利单抗治疗AChR阳性青少年(12-17岁)的Ⅱ/Ⅲ期Vibrance-MG研究的积极结果。强生新闻稿指出,这是首个在12-17岁抗体阳性青少年中表现出24周的持续疾病控制效果的FcRn阻断剂,扩大了尼卡利单抗的研究人群。
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