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FDA扩大了Soliris的适应症以治疗视神经脊髓炎谱系疾病

2019-06-28 Allan MedSci原创

SolirisFDA视神经脊髓炎谱系疾病结合水通道蛋白-4
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Alexion制药公司近日表示，FDA已批准Soliris（eculizumab）治疗成人NMOSD。来自III期PREVENT试验的数据证实了Soliris对NMOSD的有效性。该试验表明，与安慰剂相比，Soliris显著降低了NMOSD的复发风险。

视神经脊髓炎和视神经脊髓炎谱系疾病（NMOSD）是中枢神经系统炎性疾病，以免疫介导的严重脱髓鞘及轴突损伤为特征，主要累及视神经和脊髓。随着选择性结合水通道蛋白-4（aquaporin-4, AQP4）的疾病特异性血清NMO-IgG抗体的发现，人们对NMOSD的认识有所增加。

Alexion制药公司近日表示，FDA已批准Soliris（eculizumab）治疗成人NMOSD。来自III期PREVENT试验的数据证实了Soliris对NMOSD的有效性。该试验表明，与安慰剂相比，Soliris显著降低了NMOSD的复发风险。欧洲和日本对这种适应症的批准仍在审查中。


原始出处：

http://www.firstwordpharma.com/node/1650097#axzz5s0nRyue8

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    2020-01-06 xlysu

    #脊髓炎#

    0

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    2019-07-02 gj0740

    #视神经#

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    2020-05-17 snowpeakxu

    #神经脊髓炎#

    0

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    2019-06-30 仁者大医

    #适应症#

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    2019-06-30 ms8538335253054589

    #视神经脊髓炎#

    0