The Food and Drug Administration on Friday approved a new use for Sanofi and Regeneron’s top-selling immune disease drug Dupixent, clearing the medicine to treat a

美国食品药品监督管理局周五批准了赛诺菲和再生元最畅销的免疫疾病药物Dupixent的新用途，允许该药物用于治疗一种新的适应症。

chronic skin condition that causes hives

慢性皮肤病，导致荨麻疹

.

。

The agency OK’d Dupixent for chronic spontaneous urticaria, an inflammatory skin disease that causes hives to form on the body and leads to severe itching, burning or swelling. Dupixent is specifically available for people 12 years of age or older whose symptoms persist despite antihistamine treatment.

该机构批准了Dupixent用于治疗慢性自发性荨麻疹，这是一种导致身体出现风团并引发严重瘙痒、灼烧感或肿胀的炎症性皮肤病。Dupixent专门适用于12岁及以上尽管接受抗组胺治疗症状仍然持续的患者。

In a statement, Regeneron estimated more than 300,000 people in the U.S. fit that description..

再生元公司在一份声明中估计，美国有超过30万人符合这一描述。

Urticaria describes a group of hive-forming skin conditions that in recent years have become an active area of drug research. They can crop up either on their own or be induced by environmental factors, such as cold or warm temperatures, and last for weeks or even years at a time.

荨麻疹描述的是一组形成蜂窝状皮肤状况的病症，近年来已成为药物研究的活跃领域。它们可能单独出现，也可能由环境因素引发，例如寒冷或温暖的温度，并且可能持续数周甚至数年。

While people can receive antihistamines or the biologic Xolair, many don’t respond. And even if they do, relief can take weeks. Several drugmakers, including Sanofi and Regeneron,

虽然人们可以接受抗组胺药或生物制剂Xolair，但许多人没有反应。即使有反应，缓解也可能需要数周时间。包括赛诺菲和再生元在内的几家制药商，

Celldex Therapeutics

赛尔德克斯治疗公司

,

，

Jasper Therapeutics

杰斯珀治疗学公司

and

和

Novartis

诺华

, are advancing therapies they claim can improve upon standard care.

，他们正在推进一些疗法，声称这些疗法可以改进标准治疗。

Dupixent is the first of this new group to reach market, even after setbacks prolonged its development path. The drug

Dupixent是这种新药中第一个上市的，尽管挫折延长了它的开发过程。这种药物

missed the main goal

错过了主要目标

of one of its key studies in 2022. The FDA

2022年其关键研究之一的。FDA

rejected the companies' initial application

驳回了公司的初步申请

a year later and requested more efficacy data.

一年后，并要求提供更多疗效数据。

Sanofi and Regeneron provided those results in 2024 via a trial called Liberty-Cupid Study C, which enrolled patients who had uncontrolled symptoms and were taking antihistamines. They reported that patients who added Dupixent to their regimen

赛诺菲和再生元通过名为Liberty-Cupid Study C的试验提供了2024年的这些结果，该试验招募了症状未得到控制并正在服用抗组胺药的患者。他们报告称，将Dupixent添加到治疗方案中的患者

experienced an almost 50% reduction in itch and urticaria activity scores

瘙痒和荨麻疹活动评分几乎减少了50%

compared to those given a placebo. Those data were the basis for the FDA’s approval Friday.

与那些给予安慰剂的人相比。这些数据是 FDA 周五批准的基础。

“Dupixent is the first new targeted treatment for chronic spontaneous urticaria, or CSU, in over ten years, with pivotal trials demonstrating its ability to help patients significantly reduce the hallmark symptoms of intense itch and unpredictable hives associated with this disease,” said Regeneron Chief Scientific Officer, George Yancopoulos, in the company’s statement..

“Dupixent 是十多年来首个针对慢性自发性荨麻疹（CSU）的新靶向治疗药物，关键试验表明它能够帮助患者显著减轻与该疾病相关的剧烈瘙痒和不可预测的风团等标志性症状，”再生元首席科学官乔治·扬科普洛斯在公司声明中表示。

The clearance gives Dupixent, which generated

该批准给予Dupixent，其产生了

nearly $14 billion in sales

近140亿美元的销售额

last year, seven approved uses. Yet some analysts are skeptical of Dupixent’s commercial potential in urticaria. In a research note last year, analysts at Cantor Fitzgerald said they viewed Dupixent’s results in urticaria as “underwhelming” compared to the data generated so far by Celldex. In March, the investment bank Jefferies, after speaking with dermatologists, said the drug “seems a non factor” compared to other emerging agents for the condition..

去年，有七种获批的用途。然而，一些分析师对Dupixent在荨麻疹领域的商业潜力持怀疑态度。去年，康托·菲茨杰拉德的分析师在一份研究报告中表示，与Celldex迄今为止生成的数据相比，他们认为Dupixent在荨麻疹方面的结果“不尽人意”。今年三月，投资银行Jefferies在与皮肤科医生交流后表示，与其他正在出现的治疗该病症的药物相比，该药“似乎无足轻重”。

Dupixent is already approved for chronic urticaria in Japan, Brazil and the United Arab Emirates. It’s currently under regulatory review elsewhere, including in the EU.

Dupixent已在日本、巴西和阿拉伯联合酋长国获批用于治疗慢性荨麻疹。目前，它正在包括欧盟在内的其他地区接受监管审查。