诺华制药(NVS)司库奇尤单抗获批第五项适应症

金吾财讯
12 Mar

金吾财讯 | 中国国家药品监督管理局(NMPA)批准诺华制药(NVS)全人源IL-17A抑制剂司库奇尤单抗用于中重度化脓性汗腺炎(HS)成人治疗。该药物通过抑制IL-17A炎症通路,减少炎性结节和脓肿并控制复发,成为其自获批成人银屑病等适应症后的第五个应用领域。III期SUNSHINE和SUNRISE研究显示,每两周或四周注射300mg司库奇尤单抗的患者组,达到HS临床反应(HiSCR50)比例显著高于安慰剂。治疗组从第2周起效,第16周达峰值疗效并持续至52周,且在16周和52周均显示统计学显著优势。两项多中心随机双盲试验证实其快速起效及长期控制疾病的能力,为传统疗法效果不佳的患者提供新选择。

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