美国FDA受理Argenx(ARGX.US)艾加莫德皮下注射用于治疗CIDP的补充上市申请并纳入优先审评

智通财经02-20

智通财经APP获悉，荷兰生物技术公司Argenx(ARGX.US)宣布，美国食品药品监督管理局(FDA)已经受理了艾加莫德皮下注射(VYVGART Hytrulo)用于治疗慢性炎性脱髓鞘性多发性神经根神经病(CIDP)的补充生物制剂上市许可申请(sBLA)并将其纳入优先审评。处方药用户付费法案(PDUFA)目标行动日期为2024年6月21日。此次申请基于临床研究ADHERE的数据结果。ADHERE...

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