The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. The target action date for the FDA decision is April 18, 2025.

美国食品药品监督管理局 (FDA) 已接受审查 Dupixent (dupilumab) 的补充生物制品许可申请 (sBLA) 的重新提交，用于治疗使用 H1 抗组胺药治疗无法充分控制病情的慢性自发性荨麻疹 (CSU) 成人和 12 岁及以上儿童患者。FDA 决定的目标行动日期为 2025 年 4 月 18 日。

The resubmitted sBLA is supported by data from the multi-study LIBERTY-CUPID phase 3 clinical program (Study A, Study B, and Study C) for Dupixent in CSU. The sBLA adds results from Study C, which was conducted in patients with uncontrolled CSU who were on standard-of-care antihistamines. Study C, the second LIBERTY-CUPID pivotal study in biologic-naïve patients, met its primary and key secondary endpoints, confirming results seen in the previous Study A. Results showed Dupixent significantly reduced itch and urticaria activity (itch and hives).

重新提交的 sBLA 得到了多项研究 LIBERTY-CUPID 3 期临床计划的数据支持（ 研究A ， 研究 B ， 和 研究 C ) 用于治疗 CSU。sBLA 增加了研究 C 的结果，该研究是在接受标准治疗抗组胺药治疗的 CSU 未得到控制的患者中进行的。研究 C 是第二项 LIBERTY-CUPID 关键研究，研究对象为未接受过生物制剂治疗的患者，该研究达到了其主要终点和关键次要终点，证实了之前研究 A 中的结果。结果显示 Dupixent 显著减少了瘙痒和荨麻疹活动（瘙痒和荨麻疹）。

Safety results in all LIBERTY-CUPID phase 3 studies were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent (≥5%) compared to placebo were injection site reactions and COVID-19 infection.

所有 LIBERTY-CUPID 3 期研究的安全性结果与 Dupixent 在其获批适应症中的已知安全性基本一致。与安慰剂相比，Dupixent 更常见的不良事件（≥5%）是注射部位反应和 COVID-19 感染。