The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment.

美国食品和药物管理局（FDA）已批准 Dupixent（dupilumab）用于治疗 12 岁及以上、尽管接受过组胺-1（H1）抗组胺药治疗但仍有症状的慢性自发性荨麻疹（CSU）成人和青少年患者。

Kenneth Mendez

肯尼斯·门德斯

President and Chief Executive Officer at the Asthma and Allergy Foundation of America

美国哮喘和过敏基金会主席兼首席执行官

“People with chronic spontaneous urticaria experience sudden, unpredictable hives and severe itch that cause a significant, and often overwhelming, burden on their everyday lives. The approval of this treatment offers patients more options and the chance to control their disease.”

“慢性自发性荨麻疹患者会突然出现无法预测的荨麻疹和严重瘙痒，这对他们的日常生活造成了显著且常常难以承受的负担。这种治疗方案的批准为患者提供了更多选择，并有机会控制他们的病情。”

Alyssa Johnsen, M.D., Ph.D.

艾莉莎·约翰森，医学博士，哲学博士

Global Therapeutic Area Head, Immunology and Oncology Development at Sanofi

赛诺菲免疫学和肿瘤学开发全球治疗领域负责人

“CSU patients with uncontrolled disease experience highly burdensome itch and hives that can significantly disrupt daily living. This FDA approval provides a new treatment option to help address the underlying drivers of these severe and recurring signs and symptoms. Dupixent has the potential to improve outcomes for CSU patients who previously had limited treatment options.” .

“患有未控制疾病的CSU患者会经历非常严重的瘙痒和荨麻疹，这可能会显著扰乱日常生活。此次FDA的批准提供了一种新的治疗选择，有助于解决这些严重且反复出现的症状的根本原因。Dupixent有潜力改善先前治疗选择有限的CSU患者的治疗效果。”

The US approval is based on data from two phase 3 clinical studies, Study A (n=136) and Study C

美国的批准是基于两项三期临床研究的数据，研究 A(n=136) 和学习C语言

(n=148), which included biologic-naïve patients aged 12 years and older who were symptomatic despite the use of antihistamines and assessed Dupixent as an add-on therapy to standard-of-care antihistamines, compared to antihistamines alone. Both studies met their primary and key secondary endpoints with Dupixent demonstrating reductions in itch severity and urticaria activity (a composite of itch and hives) compared to placebo at 24 weeks.

(n=148)，其中包括12岁及以上使用抗组胺药后仍有症状的生物制剂初治患者，并评估了Dupixent作为标准护理抗组胺药的附加疗法，与单独使用抗组胺药进行对比。两项研究均达到了主要和关键次要终点，与安慰剂相比，Dupixent在24周时显著减轻了瘙痒严重程度和荨麻疹活动（瘙痒和风团的综合指标）。

Dupixent also increased the likelihood of well-controlled disease or complete response compared to placebo at 24 weeks. .

Dupixent在24周时相比安慰剂提高了疾病良好控制或完全缓解的可能性。

Study B

研究 B

(n=108) provided additional safety data and evaluated Dupixent in patients aged 12 years and older who were inadequate responders or intolerant to anti-IgE therapy and symptomatic despite antihistamine use.

（n=108）提供了额外的安全性数据，并在12岁及以上对IgE抗体治疗反应不佳或不耐受且使用抗组胺药仍有症状的患者中评估了Dupixent。

Safety results from Study A, Study B, and Study C were generally consistent with the known safety profile of Dupixent in its approved indications. In pooled data from all three studies, the most common adverse event (≥2%) more frequently observed in patients on Dupixent compared to placebo was injection site reactions..

研究A、研究B和研究C的安全性结果通常与Dupixent在其获批适应症中已知的安全性特征一致。在所有三项研究的汇总数据中，与安慰剂相比，接受Dupixent治疗的患者中最常见的不良事件（≥2%）是注射部位反应。

George D. Yancopoulus, M.D., Ph.D.

乔治·D·扬科普洛斯，医学博士，哲学博士

Board co-Chair, President and Chief Scientific Officer at Regeneron

再生元公司的董事会联合主席、总裁兼首席科学官

“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. With this FDA decision, Dupixent is now approved for seven chronic, debilitating atopic conditions driven in part by underlying type 2 inflammation, several of which have been shown to co-morbidly occur with CSU, such as atopic dermatitis and asthma – providing patients with one treatment that might help multiple atopy conditions.

“Dupixent 是十多年来首个用于治疗慢性自发性荨麻疹（CSU）的新型靶向疗法，其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。随着 FDA 的这一决定，Dupixent 现已获批用于七种由 2 型炎症部分驱动的慢性、致衰性特应性疾病，其中一些疾病已被证明与 CSU 共病，例如特应性皮炎和哮喘——为患者提供了一种可能对多种特应性疾病有效的治疗选择。”

We look forward to bringing Dupixent to the more than 300,000 CSU patients in the US with inadequately controlled disease on standard-of-care treatment who, until now, had limited treatment options.” .

我们期待着将Dupixent带给美国超过30万名接受标准治疗但疾病控制不佳的CSU患者，这些患者直到现在为止治疗选择有限。"

Dupixent is already approved for CSU in Japan, the United Arab Emirates, and Brazil. Submissions are currently under review with other regulatory authorities around the world including in the EU.

Dupixent已在日本、阿拉伯联合酋长国和巴西获批用于治疗CSU。目前，包括欧盟在内的全球其他监管机构正在审查提交的申请。

About CSU

关于CSU

CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch. CSU is typically treated with H1 antihistamines, medicines that target H1 receptors on cells to control symptoms of itch and urticaria. However, the disease remains uncontrolled despite antihistamine treatment in many patients, some of whom are left with limited alternative treatment options.

慢性自发性荨麻疹 (CSU) 是一种由 2 型炎症部分驱动的慢性炎症性皮肤病，会导致突发且使人衰弱的荨麻疹和反复发作的瘙痒。CSU 通常使用 H1 抗组胺药进行治疗，这类药物通过作用于细胞上的 H1 受体来控制瘙痒和荨麻疹症状。然而，尽管许多患者接受抗组胺药治疗，疾病仍然无法得到控制，其中一些患者的替代治疗选择有限。

These individuals continue to experience symptoms that can be debilitating and significantly impact their quality of life. More than 300,000 people in the US suffer from CSU that is inadequately controlled by antihistamines..

这些患者会持续出现可能令人虚弱并严重影响其生活质量的症状。美国有超过 300,000 人患有的 CSU 无法通过抗组胺药得到充分控制。

About the Dupixent CSU phase 3 study program

关于Dupixent CSU三期研究计划

The LIBERTY-CUPID phase 3 program evaluating Dupixent for CSU consists of Study A Study B , and Study C

评估Dupixent用于CSU的LIBERTY-CUPID 3期项目由研究 A研究 B，以及学习C

. These studies were randomized, double-blind, placebo-controlled clinical studies that evaluated the efficacy and safety of Dupixent as an add-on therapy to standard-of-care antihistamines compared to antihistamines alone. Studies A and C were replicate studies that assessed patients aged six years and older who remained symptomatic despite the use of antihistamines.

这些研究是随机、双盲、安慰剂对照的临床研究，评估了Dupixent作为标准护理抗组胺药的辅助疗法相较于单独使用抗组胺药的疗效和安全性。研究A和C是重复性研究，评估了六岁及以上尽管使用抗组胺药仍然有症状的患者。

Study B was conducted in patients aged 12 years and older who were symptomatic despite use of antihistamines and were inadequate responders or intolerant to anti-IgE therapy. During the 24-week treatment period in all three studies, patients received an initial loading dose followed by 300 mg Dupixent every two weeks, except for pediatric patients weighing <60 kg who received 200 mg every two weeks..

研究B纳入了12岁及以上尽管使用抗组胺药仍有症状，并且对抗IgE治疗反应不佳或不耐受的患者。在所有三项研究的24周治疗期间，患者接受了初始负荷剂量，随后每两周接受300 mg Dupixent，体重小于60公斤的儿科患者除外，他们每两周接受200 mg。

In all three studies, the primary endpoint assessed the change from baseline in itch at 24 weeks (measured by the weekly itch severity score, 0-21 scale). The key secondary endpoints (also assessed at 24 weeks) included change from baseline in itch and hives (weekly urticaria activity score [UAS7], 0-42 scale).

在所有三项研究中，主要终点评估了24周时瘙痒较基线的变化（通过每周瘙痒严重程度评分衡量，0-21分制）。关键次要终点（同样在24周评估）包括瘙痒和荨麻疹较基线的变化（每周荨麻疹活动评分[UAS7]，0-42分制）。

Additional secondary endpoints assessed at 24 weeks evaluated the proportion of patients achieving well-controlled disease status (UAS7 ≤6) and the proportion of patients with complete response (UAS7=0)..

24周时评估的其他次要终点包括达到良好疾病控制状态（UAS7 ≤6）的患者比例和完全缓解（UAS7=0）的患者比例。

The results from Studies A and B were published in The Journal of Allergy and Clinical Immunology

研究 A 和 B 的结果已发布在《过敏与临床免疫学杂志》

. Study B did not meet the primary endpoint in the US of reduction in ISS7 compared to placebo at 24 weeks.

研究 B 在美国未能达到主要终点，即在 24 周时与安慰剂相比，ISS7 的减少。

About Dupixent

关于Dupixent

Dupixent (dupilumab) is an injection administered under the skin (subcutaneous injection) at different injection sites. In adults with CSU who remain symptomatic despite H1 antihistamine treatment, Dupixent 300 mg is administered every two weeks after an initial loading dose. In patients aged 12 to 17 years with CSU who remain symptomatic despite H1 antihistamine treatment, Dupixent is administered every two weeks based on weight (200 mg for adolescents ≥30 to <60 kg, 300 mg for adolescents ≥60 kg) after an initial loading dose.

Dupixent（dupilumab）是一种在不同注射部位进行皮下注射的药物。对于尽管接受H1抗组胺治疗仍然有症状的成人CSU患者，Dupixent 300 mg在初始负荷剂量后每两周给药一次。对于尽管接受H1抗组胺治疗仍然有症状的12至17岁CSU患者，根据体重（≥30至<60 kg的青少年为200 mg，≥60 kg的青少年为300 mg），在初始负荷剂量后每两周给药一次。

Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home after training by a healthcare professional. In adolescents aged 12 to 17 years, Dupixent should be administered under the supervision of an adult..

Dupixent 需在医疗专业人员的指导下使用，经过医疗专业人员培训后可以在诊所或家中给药。对于 12 至 17 岁的青少年，Dupixent 应在成年人的监督下进行注射。

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 studies, establishing that IL4 and IL13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases..

Dupixent 是一种全人源单克隆抗体，可抑制白细胞介素-4（IL-4）和白细胞介素-13（IL-13）通路的信号传导，并非免疫抑制剂。Dupixent 的开发项目在三期研究中显示出显著的临床益处并降低了 2 型炎症，证明了 IL-4 和 IL-13 是 2 型炎症的两个关键驱动因素，这种炎症在多种相关且常为共病的疾病中起主要作用。

Sanofi and Regeneron are committed to helping patients in the US who are prescribed Dupixent gain access to the medicine and receive the support they may need with the DUPIXENT

赛诺菲和再生元致力于帮助美国被处方Dupixent的患者获得该药物，并通过DUPIXENT获得他们可能需要的支持。

Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, CSU, and chronic obstructive pulmonary disease in different age populations.

Dupixent 已在60多个国家获得监管批准，适用于一个或多个适应症，包括某些特应性皮炎、哮喘、伴鼻息肉的慢性鼻窦炎、嗜酸性食管炎、结节性痒疹、慢性自发性荨麻疹 (CSU) 以及不同年龄人群的慢性阻塞性肺疾病。

More than one million patients are being treated with Dupixent globally..

全球已有逾百万患者正在接受Dupixent的治疗。

Dupilumab development program

Dupilumab开发计划

Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical studies involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

Dupilumab由赛诺菲和再生元根据全球合作协议共同开发。迄今为止，dupilumab已经在涉及超过10,000名部分由2型炎症驱动的各类慢性疾病患者的60多项临床研究中进行了研究。

In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin, bullous pemphigoid, and lichen simplex chronicus. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority..

除了目前已批准的适应症外，赛诺菲和再生元公司正在对dupilumab进行广泛的3期临床研究，涵盖由2型炎症或其他过敏过程驱动的多种疾病，包括不明原因的慢性瘙痒、大疱性类天疱疮和慢性单纯性苔藓。这些dupilumab的潜在用途目前仍在临床研究中，其在这些病症中的安全性和有效性尚未得到任何监管机构的全面评估。

About Regeneron

关于再生元

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories.

再生元（纳斯达克代码：REGN）是一家领先的生物技术公司，致力于为患有严重疾病的患者发明、开发和商业化改变生命的药物。公司由医生科学家创立并领导，我们独特的能力在于能够反复且持续地将科学转化为药物，目前已研发出多种获批的治疗方法和正在开发的产品候选药物，其中大多数都是在我们自己的实验室中自主研发的。

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases..

我们的药物和研发管线旨在帮助患有眼疾、过敏性和炎症性疾病、癌症、心血管和代谢疾病、神经疾病、血液病、传染病和罕见病的患者。

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as

Regeneron利用我们的专有技术，如[具体技术]，推动科学发现的边界，加速药物开发。

and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

并开创基因医学平台，使我们能够识别创新靶点和互补方法，有望治疗或治愈疾病。

About Sanofi

关于赛诺菲

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions..

我们是一家创新的全球医疗保健公司，由一个目标驱动：我们追逐科学的奇迹以改善人们的生活。我们的团队遍布全球，致力于通过努力将不可能变为可能来改变医学实践。我们为全球数百万人提供可能改变生命的治疗选择和拯救生命的重要疫苗保护，同时将可持续发展和社会责任置于我们志向的核心。

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

赛诺菲在 EURONEXT（欧元区股票交易所）上市，股票代码为 SAN；同时在 NASDAQ（纳斯达克）上市，股票代码为 SNY。