治疗成人和青少年原发性体液免疫缺陷病新药ASCENIV

ASCENIV--a new approved drug for the treatment of primary immune deficiency disease

2019年4月美国食品药品监督管理局(FDA)正式批准ASCENIV(RI-002)上市用于治疗成人和青少年(12~17岁)原发性体液免疫缺陷,ASCENIV是一种多克隆、含10%人-slra的新型静脉注射用免疫球蛋白(IG)。其多克隆IG组成具有更强的中和抗呼吸道合胞病毒(RSV)活性。不仅如此,有临床前数据显示ASCENIV还可用于其他呼吸道病原体的体液保护。现对其作用机制、药效学、药动学、临床研究、安全性和注意事项等作一综述。

The US Food and Drug Administration(FDA)officially approved the marketing of ASCENIV(RI-002)for the treatment of primary humoral immune deficiency disease("PIDD")in adults and adolescents(12-17 years old)on April 2019.ASCENIV,Human-slra 10%Liquid,is a polyclonal immune globulin intravenous(IG),its polyclonal IG composition has stronger neutralizing anti-respiratory syncytial virus(RSV)activity,and preclinical data show that ASCENIVTM can be used for humoral protection of other respiratory pathogens.Now,we reviewed the mechanism of action,pharmacodynamics,pharmacokinetics,clinical research,safety and precautions about ASCENIV.