BARCELONA, Spain--(BUSINESS WIRE)--Almirall S.A. (BME: ALM) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the marketing authorization of EBGLYSS (lebrikizumab) for the treatment of adult and adolescent patients (12 years and older with a body weight of at least 40 kg) with moderate-to-severe atopic dermatitis, who are candidates for systemic therapy..

巴塞罗那，西班牙-（商业信息）-Almirall S.A.（BME:ALM）今天宣布，欧洲药品管理局（EMA）人用药品委员会（CHMP）发布积极意见，建议上市授权EBGLYSS（lebrikizumab）用于治疗中度至重度成人和青少年患者（12岁及以上，体重至少40公斤）特应性皮炎，是全身治疗的候选人。。

The positive CHMP opinion is now being reviewed by the European Commission (EC). The approval of this biologic in the European Union is expected in approximately two months and its launch in the first European country could take place soon after.

欧盟委员会（EC）正在审查积极的CHMP意见。预计该生物制剂将在大约两个月内获得欧盟的批准，并可能在不久之后在第一个欧洲国家推出。

Results from the Phase 3 clinical development program showed most patients (80 percent) who responded* to treatment with lebrikizumab at Week 16 weeks maintained skin clearance and itch relief through one year of treatment with monthly maintenance dosing.

第3阶段临床开发计划的结果显示，在第16周时对lebrikizumab治疗有反应的大多数患者（80%）通过每月维持剂量治疗一年保持皮肤清除和瘙痒缓解。

“Atopic dermatitis, commonly known as atopic eczema, can have a profound impact on the quality of life for those it affects. Lebrikizumab’s targeted mechanism of action inhibits IL-13 signaling. In clinical trials, it helped patients control their disease and maintain those results long term, over 52 weeks.

“特应性皮炎，通常称为特应性湿疹，可以对其影响的人的生活质量产生深远的影响，Lebrikizumab的靶向作用机制抑制IL-13信号传导，在临床试验中，它帮助患者控制疾病并维持这些结果长期超过52周。

Additionally, its monthly maintenance dosing regimen offers convenience and flexibility, benefiting both patients and healthcare providers. The potential inclusion of this treatment in the range of options against atopic dermatitis means a significant stride toward enhancing the quality of life of individuals struggling with this challenging skin condition” said Prof.

此外，其每月维护剂量方案提供了便利性和灵活性，使患者和医疗保健提供者受益。教授说，这种治疗方法可能包含在治疗特应性皮炎的一系列选择中，这意味着在提高应对这种具有挑战性的皮肤状况的个人的生活质量方面迈出了重要的一步。

Alan Irvine, dermatologist in Children’s Health Ireland and St. James’s Hospital, Dublin & Professor in Dermatology, Trinity College Dublin..

爱尔兰儿童健康皮肤科医生Alan Irvine和都柏林圣詹姆斯医院以及都柏林三一学院皮肤科教授。。

'The positive CHMP recommendation for EBGLYSS in moderate to severe AD represents a significant milestone in bringing a next-generation biologic therapy to people living with atopic dermatitis, providing a much needed additional treatment option. We are confident that EBGLYSS, thanks to its selective mechanism of action, proven long-term efficacy and patient friendly monthly maintenance dosing has the potential to become a first-line treatment for moderate-to-severe atopic dermatitis.' said Karl Ziegelbauer, Chief Scientific Officer at Almirall..

“中度至重度AD患者对EBGLYSS的积极CHMP建议代表了为特应性皮炎患者带来下一代生物治疗的重要里程碑，提供了急需的额外治疗方案。我们相信，由于其选择性的作用机制，EBGLYSS已被证明具有长期疗效和患者友好的每月维持剂量，有可能成为中重度特应性皮炎的一线治疗药物Almirall首席科学官Karl Ziegelbauer说。。

The cytokine IL-13 is key in atopic dermatitis, driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection.1-6 Lebrikizumab binds to IL-13 protein with high affinity and specifically inhibits its downstream signaling.7-8

细胞因子IL-13是特应性皮炎的关键，驱动皮肤中的2型炎症环，导致皮肤屏障功能障碍，瘙痒，皮肤增厚和感染.1-6 Lebrikizumab以高亲和力与IL-13蛋白结合，特异性抑制其下游信号

The CHMP opinion is based on three pivotal Phase 3 studies† including ADvocate 1 and ADvocate 2, evaluating lebrikizumab as monotherapy, and ADhere, assessing lebrikizumab in combination with topical corticosteroids (TCS), in adult and adolescent patients with moderate-to-severe atopic dermatitis. At Week 16, more than 50 percent of patients with moderate-to-severe atopic dermatitis experienced at least 75 percent reduction in disease severity (EASI-75) when receiving lebrikizumab monotherapy in the ADvocate studies and nearly 70 percent of patients receiving lebrikizumab combined with standard-of-care TCS achieved EASI-75 in the ADhere trial..

CHMP意见基于三个关键的3期研究†包括ADVOTE 1和ADVOTE 2，评估lebrikizumab作为单一疗法，并坚持评估lebrikizumab联合局部皮质类固醇（TCS），成人和青少年中度至重度特应性皮炎。在第16周，在ADvocate研究中接受lebrikizumab单药治疗时，超过50%的中重度特应性皮炎患者的疾病严重程度（EASI-75）至少降低75%，接受lebrikizumab联合标准治疗的患者中近70%的患者TC在ADhere试验中达到了EASI-75。。

The Phase 3 clinical development program also evaluated the safety profile of lebrikizumab. Most adverse events (AE) across the studies were mild or moderate in severity nonserious, and did not lead to treatment discontinuation. The most common adverse reactions were conjunctivitis, injection site reactions, conjunctivitis allergic and dry eye..

3期临床开发计划还评估了lebrikizumab的安全性。整个研究中的大多数不良事件（AE）轻度或中度严重程度不严重，并未导致治疗中止。最常见的不良反应是结膜炎，注射部位反应，结膜炎过敏和干眼症。。

Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including atopic dermatitis, in Europe. Eli Lilly and Company has exclusive rights for the development and commercialization of the product in the United States and the rest of the world, not including Europe.

Almirall已获准在欧洲开发和商业化lebrikizumab用于治疗皮肤病适应症，包括特应性皮炎。礼来公司拥有在美国和世界其他地区（不包括欧洲）开发和商业化产品的专有权。

Almirall expects regulatory decisions for lebrikizumab in moderate-to-severe atopic dermatitis in additional European markets, including the United Kingdom and Switzerland in 2024..

Almirall预计2024年将在其他欧洲市场（包括英国和瑞士）对中度至重度特应性皮炎的lebrikizumab作出监管决定。。

† More information about the Phase 3 studies: ADvocate 1: EudraCT Number 2019-002932-10; NCT04146363; ADvocate 2: EudraCT Number 2019-002933-12; NCT04178967; Adhere: EudraCT Number 2019-004300-34; NCT04250337

†关于第3阶段研究的更多信息：倡导1:EudraCT号码2019-002932-10；NCT04146363；倡导者2:EudraCT号码2019-002933-12；NCT04178967；Adhere:EudraCT号码2019-004300-34；NCT04250337

*Responders were defined as those achieving a 75% reduction in the Eczema Area and Severity Index from baseline (EASI-75) or an IGA 0 or 1 (“clear” or “almost clear”) with at least 2-point improvement and without rescue medication use at Week 16. At Week 16, responders were re-randomized to lebrikizumab 250 mg every two weeks or four weeks or placebo for an additional 36 weeks..

*应答者定义为湿疹面积和严重程度指数从基线（EASI-75）或IGA 0或1（“清除”或“几乎清除”）降低75%且至少2分改善且无救援药物使用在第16周。在第16周，应答者被重新随机分配到每两周或四周250mg lebrikizumab或安慰剂另外36周。。

About lebrikizumab and Clinical Development Program

关于lebrikizumab和临床开发计划

Lebrikizumab is an investigational, monoclonal antibody that binds IL-13 with high affinity to specifically prevent the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13.7-8 The cytokine IL-13 is key in atopic dermatitis, driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection.1-6.

Lebrikizumab是一种研究性单克隆抗体，以高亲和力结合IL-13，特异性地阻止IL-13Rα1/IL-4Rα异二聚体复合物的形成和随后的信号传导，从而抑制IL-13.7-8的生物学效应。细胞因子IL-13是特应性皮炎的关键，驱动皮肤中的2型炎症环，导致皮肤屏障功能障碍，瘙痒，皮肤增厚和感染。

The lebrikizumab phase III program consists of five key global studies evaluating over 1,300 patients, including two monotherapy studies (ADvocate 1 and 2), a combination study with topical corticosteroids (ADhere), as well as long-term extension (ADjoin) and adolescent open label (ADore) studies.

lebrikizumab III期计划包括五项关键的全球研究，评估1300多名患者，包括两项单药治疗研究（ADvocate 1和2），局部皮质类固醇联合研究（ADhere），以及长期延长（ADjoin）和青少年开放标签（ADore）研究。

About Almirall

阿尔米拉利

Almirall is a global biopharmaceutical company focused on medical dermatology. We collaborate with scientists and healthcare professionals to address patients' needs through science to improve their lives. Our Noble Purpose is at the core of our work: 'Transform the patients' world by helping them realize their hopes and dreams for a healthy life'.

Almirall是一家专注于医学皮肤病学的全球生物制药公司。我们与科学家和医疗保健专业人员合作，通过科学解决患者的需求，改善他们的生活。我们崇高的目标是我们工作的核心：“帮助患者实现健康生活的希望和梦想，改变患者的世界”。

We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need..

我们投资差异化和突破性的医用皮肤科产品，为有需要的患者带来创新的解决方案。。

The company, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM). Throughout its 79-year history, Almirall has focused intensely on patients' needs. Almirall has a direct presence in 21 countries and strategic agreements in over 70, with about 1,800 employees.

该公司成立于1944年，总部设在巴塞罗那，在西班牙证券交易所（证券交易所：ALM）上市交易。在其79年的历史中，Almirall一直专注于患者的需求。Almirall在21个国家直接存在，70多个国家拥有战略协议，约有1800名员工。

Total revenue in 2022 was €878.5 MM..

2022年的总收入为878.5毫米。。

For more information, please visit almirall.com

欲了解更多信息，请访问almirall.com

Legal warning

法律警告

This document includes only summary information and is not intended to be exhaustive. The facts, figures and opinions contained in this document, in addition to the historical ones, are 'forward-looking statements'. These statements are based on the information currently available and the best estimates and assumptions that the company considers reasonable.

本文档仅包含摘要信息，并非详尽无遗。本文件中包含的事实，数字和意见，除了历史之外，都是“前瞻性声明”。这些陈述是基于目前可用的信息以及公司认为合理的最佳估计和假设。

These statements involve risks and uncertainties beyond the control of the company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The company expressly waives any obligation to revise or update any forward-looking statements, goals or estimates contained in this document to reflect any changes in the assumptions, events or circumstances on which such forward-looking statements are based, unless required by the applicable law..

这些陈述涉及公司无法控制的风险和不确定性。因此，实际结果可能与此类前瞻性声明所声明的结果大不相同。除非适用法律另有要求，否则本公司明确放弃修改或更新本文档中包含的任何前瞻性声明，目标或估计的义务，以反映此类前瞻性声明所基于的假设，事件或情况的任何变化。。

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