THURSDAY, July 24, 2025 — The U.S. Food and Drug Administration (FDA) has signed off on the first-ever cream specifically approved for treating chronic hand eczema (CHE).

2025年7月24日，星期四 —— 美国食品和药物管理局 (FDA) 批准了首个专门用于治疗慢性手部湿疹 (CHE) 的乳膏。

CHE is common condition marked by redness, itching and cracking on the hands and wrists.

手部湿疹是一种常见疾病，表现为手部和手腕的红肿、瘙痒和开裂。

Anzupgo

安祖普戈

(delgocitinib cream) is approved for adults with moderate-to-severe CHE who can’t use topical steroids or who don’t respond well to them.

（delgocitinib乳膏）适用于不能使用外用类固醇或对外用类固醇反应不佳的中度至重度CHE成人患者。

'The approval of Anzupgo reinforces our commitment to investing in difficult-to-treat skin conditions to deliver new treatments to patients where the need is greatest,'

“Anzupgo的获批进一步印证了我们致力于投资于难治性皮肤疾病，为需求最迫切的患者提供新的治疗方案。”

Christophe Bourdon

克里斯托夫·布尔东

, CEO of LEO Pharma, maker of Anzupgo, said in a news release.

，安祖戈制造商LEO制药公司的首席执行官在新闻发布会上表示。

Unlike atopic dermatitis, which is the most common form of

与特应性皮炎不同，特应性皮炎是最常见的形式

eczema

湿疹

, CHE is rare and debilitating. It affects about 10% of the U.S. population and lasts for more than three months or recurs at least twice a year, according to the National Eczema Association.

，CHE 罕见且令人虚弱。根据国家湿疹协会的数据，它影响了美国约 10% 的人口，并且持续时间超过三个月或每年至少复发两次。

Anzupgo works by blocking the effects of JAK enzymes, which trigger the inflammation that can kickstart a hand eczema flare.

Anzupgo通过阻断JAK酶的作用来工作，JAK酶会触发可能导致手部湿疹发作的炎症。

Genetics and exposure to irritants and allergens are contributing causes of this form of eczema. Folks who are most at risk work in industries such as cleaning, hairdressing and health care, where they are more likely to come into contact with and react to chemicals.

遗传因素以及接触刺激物和过敏原是这种湿疹的诱因。最有可能患上这种疾病的人群从事清洁、美发和医疗保健等行业，因为他们更容易接触化学品并对其产生反应。

Studies show that the condition can take a dramatic toll on a person’s quality of life and mental well-being.

研究表明，这种情况可能对一个人的生活质量和心理健康造成严重影响。

A Detroit dermatologist welcomed the FDA’s action.

底特律的一位皮肤科医生对FDA的行动表示欢迎。

“In my career as a dermatologist, I have witnessed firsthand the significant burden that the itch and pain of CHE places on patients, and the challenges they face living with it,”

“在我作为皮肤科医生的职业生涯中，我亲眼目睹了慢性手部湿疹（CHE）的瘙痒和疼痛给患者带来的沉重负担，以及他们面对的生活挑战。”

Dr. Linda Stein Gold

琳达·斯坦·戈尔德博士

, director of clinical research at Henry Ford Health in Detroit, said in a LEO Pharma US news release. 'I believe this new treatment option will be welcomed by dermatologists who are looking for effective and safe ways to address these symptoms.”

底特律亨利福特健康中心的临床研究主任在LEO制药美国新闻发布会上表示：“我相信这种新的治疗选择将受到皮肤科医生的欢迎，他们一直在寻找有效且安全的方法来应对这些症状。”

Studies leading up to the FDA approval found that people with hand eczema who used the cream were more likely to improve than their counterparts treated with a placebo or dummy cream. The cream does not carry the same boxed warning that other topical and oral JAK inhibitors must.

在FDA批准前进行的研究发现，使用该药膏的手部湿疹患者比使用安慰剂或假药膏的对照组更容易改善。该药膏没有其他局部和口服JAK抑制剂必须标注的黑框警告。

“We’re thrilled that the FDA recognizes the impact that moderate-to-severe chronic hand eczema has on patients,”

“我们很高兴FDA认识到中度至重度慢性手部湿疹对患者的影响，”

Kristin Belleson

克里斯汀·贝勒森

, CEO and president of the National Eczema Association, said in a news release.

，国家湿疹协会的首席执行官兼主席，在新闻发布会上表示。

“People living with a debilitating skin disease on their hands find it extremely difficult; it can impact their ability to work, touch, and connect with important people in their lives,' she added. 'The approval … provides hope and promise for the eczema community and those seeking lasting relief from disruptive symptoms.”.

“手上患有严重皮肤病的人感到非常痛苦；这会影响他们的工作能力、触觉，以及与生活中重要人物的联系，”她补充道。“这一批准……为湿疹患者群体和那些寻求摆脱烦人症状持久缓解的人带来了希望和前景。”

The cream was already approved in the European Union, United Kingdom, Switzerland and United Arab Emirates.

该面霜已获欧盟、英国、瑞士和阿联酋批准。

Whatever your topic of interest,

无论你感兴趣的话题是什么，

subscribe to our newsletters

订阅我们的新闻通讯

to get the best of Drugs.com in your inbox.

获取 Drugs.com 的最佳资讯到您的邮箱。