诺华制药(NVS.US)“司库奇尤单抗”在中国获批第五项适应症

智通财经
12 Mar

智通财经APP获悉,3月12日,诺华制药(NVS.US)刚刚宣布其创新生物制剂司库奇尤单抗获得中国国家药品监督管理局(NMPA)批准,用于治疗中重度化脓性汗腺炎(反常性痤疮)的成人患者。作为一款全人源白介素IL-17A抑制剂,司库奇尤单抗可显著减少炎性结节和脓肿,控制病情的复燃,为HS治疗提供了全新选择。根据诺华新闻稿介绍,此次司库奇尤单抗新适应症的获批,也是继成人银屑病、儿童银屑病、强直性脊柱炎、银屑病关节炎后获批的第五个适应症。

司库奇尤单抗HS适应症的获批是基于3期研究项目SUNSHINE和SUNRISE的分析,其中每两周或每四周使用300毫克司库奇尤单抗的患者中,获得化脓性汗腺炎临床反应(HiSCR50)的比例高于安慰剂。这两项研究还评估了司库奇尤单抗在16周(与安慰剂相比)和52周治疗期的作用,司库奇尤单抗的作用早在第2周就开始了,疗效逐渐增加到第16周,并一直观察到第52周。

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