艾伯维(ABBV.US)利生奇珠单抗新适应症在华获批 用于治疗溃疡性结肠炎

智通财经
Jan 22

智通财经APP获悉,1月22日,艾伯维(ABBV.US)宣布利生奇珠单抗(risankizumab,商品名:喜开悦)在华获批第二项适应症,用于治疗对传统治疗或生物制剂治疗应答不足、失应答或不耐受的中重度活动性溃疡性结肠炎(UC)成年患者。

利生奇珠单抗是一种IL-23抑制剂,可通过与IL-23p19亚基结合来选择性阻断IL-23。IL-23是一种参与炎症过程的细胞因子,被认为与许多慢性免疫介导疾病有关。

此次获批新适应症是基于INSPIRE和COMMAND两项III期临床试验的积极结果。

结果显示,在INSPIRE诱导治疗试验中,与安慰剂相比,利生奇珠单抗治疗12周显著提高了临床缓解率(20.3% vs 6.2%;调整后组间差异14.0%[95% CI:10.0%–18.0%];P<0.001);在COMMAND维持治疗试验中,180mg和360mg两种维持剂量治疗52周的临床缓解率均显著优于安慰剂组(40.2% vs 37.6% vs 25.1%)。

2025年3月10日,利生奇珠单抗在中国首次获批上市,用于治疗对传统治疗或生物制剂治疗应答不足、失应答或不耐受的中重度活动性克罗恩病成年患者。

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