诺华的牛皮癣药物IL-17单抗Cosentyx在国内获批上市

2019-04-04 不详 MedSci原创

中国国家医疗产品管理局(NMPA)批准诺华的IL-17单抗Cosentyx(苏金单抗)用于治疗中度至重度斑块状银屑病的成年患者。Cosentyx是目前在国内第一个获批的IL-17单抗药物,领先于礼来公司的Taltz(ixekizumab)和Bausch Health的Siliq(布罗达单抗),和强生公司Tremfya(guselkumab)。

中国国家医疗产品管理局(NMPA)批准诺华的IL-17单抗Cosentyx(苏金单抗)用于治疗中度至重度斑块状银屑病的成年患者。Cosentyx是目前在国内第一个获批的IL-17单抗药物,领先于礼来公司的Taltz(ixekizumab)、Bausch Health的Siliq(布罗达单抗)和强生公司Tremfya(guselkumab)。

此次批准意味着中国牛皮癣严重患者,有了一种新的治疗方案,可"在三周内发挥疗效,并且已经在全球超过200000名患者中表现出持续的安全性"。

诺华表示,中国约有600万人患有牛皮癣,但到目前为止,中度至重度症状的患者仅限于使用甲氨蝶呤、环孢菌素和阿维A等较老的全身免疫抑制药物治疗,这些药物具有明显的副作用。

正在进行的CAIN457A2318研究,在543名中重度斑块状银屑病患者(包括441名中国患者)中将Cosentyx与安慰剂进行比较。该研究的初步结果显示,接受Cosentyx治疗的10名患者中有9名在16周后皮肤变得清晰或几乎清晰。

2018年,Cosentyx的销售额为28亿美元,比2017年增长了三分之一以上,但预计将面临来自IL-23单抗Tremfya的竞争,后者正在快速增长,去年的收入超过5.4亿美元。

原始出处:


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    2019-10-10 weiz
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    2019-04-06 fzwish20000
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    2019-04-06 jjjiang0202

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AbbVie今天宣布欧洲药品管理局(EMA)人用医药产品委员会(CHMP) 推荐将SKYRIZI(risankizumab)是一种研究性白细胞介素-23(IL-23)单抗,用于治疗成人患者的中度至重度斑块状银屑病。

2019 AAD/NPF指南:应用生物制剂治疗银屑病

2019年2月,美国皮肤病学会(AAD)联合国家银屑病基金会(NPF)共同发布了生物制剂治疗银屑病指南,银屑病是一种慢性炎症性多系统疾病,该指南解决了应用生物制剂治疗银屑病的重要临床问题,并根据现有证据提供指导建议。

全球首批!艾伯维银屑病新药在日本上市

3月27日,艾伯维(AbbVie)宣布,该公司与勃林格殷格翰(Boehringer Ingelheim)公司联合开发的IL-23抑制剂Skyrizi (risankizumab)获得日本厚生劳动省(MHLW)批准上市,用于治疗斑块状银屑病(牛皮癣),泛发性脓疱型银屑病,红皮病型牛皮癣和银屑病关节炎成年患者。这些患者在使用传统疗法后症状未能得到足够改善。这是Skyrizi全球首次获批上市。