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Dupixent在欧盟获得批准用于儿童特应性皮炎

2020-11-30 Allan MedSci原创

欧盟委员会已批准赛诺菲和再生元的生物制剂Dupixent,允许其用于治疗6至11岁的儿童特应性皮炎。

欧盟委员会已批准赛诺菲和再生元的生物制剂Dupixent,允许其用于治疗6至11岁的儿童特应性皮炎。该批准主要基于Dupixent(dupilumab)联合局部皮质类固醇(TCS)的关键III期疗效和安全性研究的数据,Dupixent组患者的平均改善率为82%,而单独使用TCS的患者的平均改善率为49%。

每两周服用一次Dupixent时,参与者表现出疾病程度和严重程度的显著改善。此外,分别每四周和两周使用Dupixent(dupilumab)+TCS时,有33%和39%的患者获得了透明或几乎透明的皮肤,而安慰剂组组的这一数据分别为11%和10%。每四周和两周施用一次,这种生物疗法还可以使瘙痒减少51%和61%,而安慰剂的这一数据分别为12%和13%。

Regeneron首席科学官George Yancopoulos说:“Dupixent是一种新颖的疗法,Dupixent已被全世界成千上万的患者使用,包括患有特应性皮炎的患者以及其他炎性疾病患者,例如慢性鼻窦炎”。

 

原始出处:

http://www.pharmatimes.com/news/dupixent_cleared_by_eu_for_atopic_dermatitis_in_children_1358679

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    2020-12-06 gqylhd

    这是一种单抗的生物制剂吗

    0

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