艾伯维向欧洲药品管理局提交Skyrizi®(瑞莎珠单抗)皮下诱导治疗申请,针对中重度活动性克罗恩病成人患者

美股速递
Aug 27

艾伯维公司(AbbVie)已正式向欧洲药品管理局(EMA)递交了一项监管申请,旨在寻求Skyrizi®(瑞莎珠单抗)皮下注射剂型的上市许可。该申请针对的适应症为——用于治疗患有中重度活动性克罗恩病的成年患者,且此方案将作为诱导治疗手段。

这一举措标志着艾伯维在炎症性肠病治疗领域的最新战略推进。克罗恩病作为一种慢性、进展性的消化系统炎症性疾病,长期以来困扰着全球数百万患者,其治疗方案的优化与创新始终是医学界关注的热点。若此次申请获得批准,Skyrizi®的皮下给药方式将为患者提供更为便捷的治疗选择,有望改善治疗依从性与患者体验。

值得注意的是,艾伯维此前已就该药物在其他适应症领域展开了广泛的临床研究与监管布局。此次针对克罗恩病皮下诱导治疗的申请,进一步丰富了Skyrizi®的潜在临床应用范围。行业分析师指出,此举不仅体现了公司对胃肠道疾病管线的持续投入,也可能在未来重塑中重度克罗恩病治疗格局。目前,该申请正处于欧洲药品监管机构的审评流程之中。

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