牛皮癣新药ilumya获批上市,75%中度至重度牛皮癣患者有益

2018-03-23 Heather_z727 来宝网

2018年3月21日新华美通太阳制药公司今天宣布,美国食品和药物管理局(FDA)批准了Ilumya为中度至重度牛皮癣患者全身治疗或光疗治疗的候选药物。ilumya选择性结合到IL-23 p19的亚基,抑制其与IL-23受体,导致促炎细胞因子和趋化因子的释放的抑制作用。Ilumya采用100 mg皮下注射,每12周给药一次,40周后完成初始剂量。

FDA批准ilumya用于治疗中度至重度斑块型银屑病】2018年3月21日新华美通太阳制药公司今天宣布,美国食品和药物管理局(FDA)批准了Ilumya为中度至重度牛皮癣患者全身治疗或光疗治疗的候选药物。ilumya选择性结合到IL-23 p19的亚基,抑制其与IL-23受体,导致促炎细胞因子和趋化因子的释放的抑制作用。Ilumya采用100 mg皮下注射,每12周给药一次,40周后完成初始剂量。

北美洲太阳制药负责人表示:“在临床试验中,我们专注于ilumya对于不同程度牛皮癣患者的作用,以人为本,测试药物的安全性和有效性,致力于为牛皮癣患者提供最佳的治疗选择。”

对于ilumya针对中度至重度斑块型银屑病的治疗, FDA的批准是以关键的第三阶段临床开发计划的数据为基础的。在两个多中心,随机,双盲,安慰剂对照的临床试验中,926例成人患者被分为两组,其中616名患者采用ilumya治疗,其余的310名采用安慰剂治疗。初次研究结果发表在2017年7月的《柳叶刀》杂志中,以及皮肤性病学第二十五欧洲学会(EADV)大会上。

在III期试验中,与安慰剂相比,100毫克ilumya至少使75%的皮肤间隙测量有显着的临床改善。在Ilumya治疗的受试者在临床试验中发生血管性水肿和荨麻疹病例。如果发生严重的过敏反应,停止ilumya立即采取适当的治疗。除此之外,ilumya可能增加感染风险。

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    2018-08-19 weiz
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    2018-03-24 1209e435m98(暂无昵称)

    学习了.谢谢分享

    0

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    2018-03-23 sunfeifeiyang

    0

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