FDA To Revisit Regeneron/Sanofi's Dupixent For Rare Skin Disease
FDA To Revisit Regeneron/Sanofi's Dupixent For Rare Skin Disease
On Friday, the FDA accepted for review the resubmission of the supplemental biologics license application (sBLA) for Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi SA's (NASDAQ:SNY) Dupixent (dupilumab) for patients ages 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment.
周五，FDA接受了再生元制药公司（纳斯达克：REGN）和赛诺菲安万特（纳斯达克：SNY）的Dupixent（dupilumab）的补充生物制品许可证申请（sBLA）的重新提交，针对12岁及以上的慢性自发性荨麻疹（CSU）患者，其疾病未能在H1抗组胺治疗中得到有效控制。
The target action date for the FDA decision is April 18, 2025.
FDA决定的目标行动日期为2025年4月18日。
Data from the multi-study LIBERTY-CUPID phase 3 clinical program (Study A, Study B, and Study C) for Dupixent in CSU support the resubmitted supplemental marketing.
来自多项研究的LIBERTY-CUPID III期临床项目（研究A、研究B和研究C）针对Dupixent在CSU中的数据支持了重新提交的补充市场申请。
Also Read: Regeneron/Sanofi's Dupixent Approval Signals Major Treatment Breakthrough For Smokers' Lung Disease
另请阅读：再生元/赛诺菲的Dupixent批准标志着吸烟者肺病治疗的重大突破。
Earlier this year, Japan was the first country in the world to approve and launch Dupixent for adult and adolescent CSU patients based on the results from Study A.
今年早些时候，日本成为全球第一个批准并推出Dupixent用于成人和青少年CSU患者的国家，基于研究A的结果。
The supplemental marketing adds results from Study C, 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 the results of the previous Study A.
补充市场申请增加了研究C的结果，该研究在接受标准治疗抗组胺药的无法控制的CSU患者中进行。研究C是生物制品未曾接触患者的第二个LIBERTY-CUPID关键研究，达到了其主要和关键次要终点，确认了之前研究A的结果。
Results showed that Dupixent significantly reduced itch and urticaria activity (itch and hives).
结果显示，Dupixent显著减少了瘙痒和荨麻疹活动（瘙痒和风团）。
In March 2023, the FDA accepted the supplemental marketing application for Dupixent (dupilumab) to treat adults and adolescents with chronic spontaneous urticaria, with the target action date for the FDA decision of October 22, 2023.
在2023年3月，FDA接受了Dupixent（dupilumab）的补充市场申请，以治疗成人和青少年慢性自发性荨麻疹，FDA决定的目标行动日期为2023年10月22日。
In October 2023, the FDA issued a Complete Response Letter for the supplemental Biologics License Application and stated that additional efficacy data are required to support approval.
在2023年10月，FDA针对补充生物制品许可证申请发出了完整回应函，并表示需要额外的有效性数据以支持批准。
It did not identify any issues with safety or manufacturing.
它没有发现任何安全性或制造业-半导体方面的问题。
CSU is a chronic inflammatory skin disease driven partly by type-2 inflammation, which causes sudden hives and recurring itch.
慢性自发性荨麻疹（CSU）是一种慢性炎症性皮肤疾病，部分由2型炎症驱动，导致突然出现荨麻疹和反复瘙痒。
CSU is typically treated with H1 antihistamines, medicines that target H1 receptors on cells to control urticaria symptoms.
慢性自发性荨麻疹通常使用H1抗组胺药物治疗，这些药物靶向细胞上的H1受体以控制荨麻疹症状。
More than 300,000 people in the US suffer from CSU that is inadequately controlled by antihistamines.
美国有超过30万人患有未能通过抗组胺药物有效控制的CSU。
Price Action: REGN stock closed at $782.51 on Thursday, and SNY stock is up 1.09% at $48.34 during the premarket session at last check Friday.
价格动态：再生元制药公司（REGN）股票周四收于782.51美元，赛诺菲安万特（SNY）股票在周五最后一次检查时在盘前交易时上涨1.09%，达到48.34美元。
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Photo: Shutterstock
Photo: shutterstock
