)--Galderma (SWX:GALD) today announced that the European Commission has approved Nemluvio

)--Galderma（SWX:GALD）今天宣布，欧盟委员会已批准Nemluvio

for both moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union (EU). Nemluvio is now approved for subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy..

适用于欧盟（EU）的中度至重度特应性皮炎和结节性痒疹。Nemluvio现在被批准用于皮下治疗12岁及以上全身治疗候选人的中度至重度特应性皮炎，以及用于皮下治疗全身治疗候选人的中度至重度结节性痒疹成人。。

“Throughout Galderma’s four decades in dermatology we have consistently worked to meet the needs of patients and deliver first-in-class treatment options. This has been exemplified through the clinical and regulatory success achieved with our unique monoclonal antibody, Nemluvio. As the first biologic treatment in our Therapeutic Dermatology portfolio, Nemluvio shows our commitment to advancing dermatology by expanding into new areas of need.”.

“在Galderma从事皮肤病学的四十年中，我们一直致力于满足患者的需求，并提供一流的治疗选择。我们独特的单克隆抗体Nemluvio在临床和监管方面取得的成功就是例证。作为我们治疗性皮肤病学组合中的第一种生物治疗方法，Nemluvio通过扩展到新的需求领域，展示了我们对推进皮肤病学的承诺。”。

is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.

是第一个被批准的特异性靶向IL-31受体α的单克隆抗体，可抑制IL-31的信号传导。

IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in both atopic dermatitis and prurigo nodularis, and fibrosis in prurigo nodularis.

IL-31是一种神经免疫细胞因子，可引起瘙痒，并参与特应性皮炎和结节性痒疹的炎症和皮肤屏障功能障碍，以及结节性痒疹的纤维化。

It is also the first and only biologic approved for atopic dermatitis and prurigo nodularis with four-week dosing intervals from the start of treatment.

它也是第一个也是唯一一个被批准用于特应性皮炎和结节性痒疹的生物制剂，从治疗开始起每隔四周给药一次。

This approval is based on results from the phase III ARCADIA and OLYMPIA clinical trial programs, in which Nemluvio significantly improved itch, skin lesions and sleep disturbance, in patients with moderate-to-severe atopic dermatitis and adults with prurigo nodularis, respectively.

该批准基于ARCADIA和OLYMPIA III期临床试验计划的结果，其中Nemluvio分别显着改善中度至重度特应性皮炎患者和结节性痒疹患者的瘙痒，皮肤病变和睡眠障碍。

Results from the ARCADIA 1 and ARCADIA 2 trials demonstrated that patients treated with Nemluvio, administered subcutaneously every four weeks in combination with background topical corticosteroids, with or without topical calcineurin inhibitors (+TCS/TCI), showed statistically significant improvements on skin clearance in both co-primary endpoints at Week 16, when compared to placebo +TCS/TCI..

来自ARCADIA 1和ARCADIA 2试验的结果表明，与安慰剂+TCS/TCI相比，每四周皮下注射Nemluvio联合背景局部皮质类固醇，有或没有局部钙调神经磷酸酶抑制剂（+TCS/TCI）的患者在第16周的两个共同主要终点的皮肤清除率均显示出统计学上的显着改善。。

The trials also met all key secondary endpoints, confirming significant responses on itch as early as Week 1 and statistically significant improvements in sleep disturbance.

这些试验还满足了所有关键的次要终点，证实了早在第1周对瘙痒的显着反应以及睡眠障碍的统计学显着改善。

Both co-primary endpoints were also met in the OLYMPIA 1 and OLYMPIA 2 clinical trials, where Nemluvio monotherapy demonstrated significant and clinically meaningful improvements on itch and skin lesions at Week 16, when compared to placebo.

在OLYMPIA 1和OLYMPIA 2临床试验中也达到了这两个共同的主要终点，与安慰剂相比，Nemluvio单药治疗在第16周对瘙痒和皮肤病变表现出显着且具有临床意义的改善。

The trials met all key secondary endpoints, showing rapid reduction in itch due to prurigo nodularis and sleep disturbance within four weeks of treatment initiation.

这些试验符合所有关键的次要终点，显示在治疗开始后四周内，结节性痒疹和睡眠障碍引起的瘙痒迅速减轻。

Nemluvio was well tolerated in all trials, and its safety profile was generally consistent with earlier data, and between trials.

Nemluvio在所有试验中都具有良好的耐受性，其安全性与早期数据以及试验之间基本一致。

“Atopic dermatitis and prurigo nodularis can severely impact quality of life due to the associated debilitating symptoms, including chronic itch, skin lesions, poor sleep quality and mental health conditions. With this approval, patients in the EU have a new treatment option, which extensive data has shown can help to safely, quickly, and effectively ease the key symptoms of these diseases and therefore the burden on patients’ lives.”.

“特应性皮炎和结节性痒疹由于相关的衰弱症状，包括慢性瘙痒，皮肤病变，睡眠质量差和心理健康状况，可严重影响生活质量。经批准，欧盟患者有了新的治疗选择，大量数据显示，这有助于安全，快速，有效地缓解这些疾病的关键症状，从而减轻患者的生活负担。”。

PROFESSOR DIAMANT THAÇI

DIAMANT THAÇI教授

LEAD INVESTIGATOR OF THE ARCADIA STUDIES IN EUROPE

欧洲阿卡迪亚研究首席研究员

UNIVERSITY OF LUBECK, GERMANY

德国吕贝克大学

“Nemolizumab’s benefits have been demonstrated in its comprehensive clinical trial programs in both atopic dermatitis and prurigo nodularis, including the OLYMPIA 1 and 2 studies, which make up the largest completed pivotal program in prurigo nodularis to date. These clinical data, plus its first-in-class mechanism of action and convenient dosing schedule, make it an important new therapeutic solution for dermatologists to support their patients.”.

“Nemolizumab在特应性皮炎和结节性痒疹的综合临床试验计划中已经证明了其益处，包括奥林匹亚1号和2号研究，这是迄今为止结节性痒疹中完成的最大的关键项目。这些临床数据，加上其一流的作用机制和方便的给药时间表，使其成为皮肤科医生支持患者的重要新治疗方案。”。

PROF. SONJA STÄNDER

教授. 索尼娅·斯坦德

LEAD INVESTIGATOR OF THE OLYMPIA STUDIES IN EUROPE

欧洲奥林匹亚研究首席研究员

UNIVERSITY HOSPITAL MÜNSTER, GERMANY

德国明斯特大学医院

Nemluvio is also approved by the U.S. Food and Drug Administration for the treatment of atopic dermatitis and prurigo nodularis.

Nemluvio还被美国食品和药物管理局批准用于治疗特应性皮炎和结节性痒疹。

It is under review for the treatment of both diseases by several additional regulatory authorities around the world, including Canada, Brazil, and South Korea, and via the Access Consortium framework in countries such as Australia, Singapore and Switzerland. Further submissions to other regulatory authorities are ongoing..

包括加拿大、巴西和韩国在内的世界其他几个监管机构正在审查这两种疾病的治疗情况，并通过澳大利亚、新加坡和瑞士等国的Access Consortium框架进行审查。正在向其他监管机构提交进一步的资料。。

As previously communicated, peak sales of Nemluvio are expected to reach more than 2 billion USD (expected beyond the 2023-2027 mid-term guidance period). Galderma anticipates Nemluvio to approach ‘blockbuster’ net sales run-rate by the end of 2027.

如前所述，Nemluvio的峰值销售额预计将超过20亿美元（预计在2023-2027年中期指导期之后）。Galderma预计Nemluvio将在2027年底达到“轰动一时”的净销售运行率。

About Nemluvio

关于Nemluvio

was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan and Taiwan. In Japan, nemolizumab is marketed as Mitchga

最初由Chugai Pharmaceutical Co.，Ltd.开发。2016年，Galderma获得了nemolizumab全球开发和销售的专有权，日本和台湾除外。在日本，nemolizumab被称为Mitchga

and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.

并被批准用于治疗结节性痒疹，以及小儿，青少年和成年患者与特应性皮炎相关的瘙痒症。

About the ARCADIA clinical trial program

关于阿卡迪亚临床试验计划

The ARCADIA program included two identically designed, pivotal phase III clinical trials, which enrolled more than 1,700 patients – ARCADIA 1 and ARCADIA 2.

阿卡迪亚计划包括两项设计相同的关键性III期临床试验，共招募了1700多名患者-阿卡迪亚1号和阿卡迪亚2号。

These global, randomized, multicenter, double-blind, placebo-controlled phase III clinical trials evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks compared to placebo (both administered with background topical corticosteroids with or without topical calcineurin inhibitors)..

这些全球性，随机，多中心，双盲，安慰剂对照的III期临床试验评估了与安慰剂相比，每四周皮下注射nemolizumab的疗效和安全性（均使用背景局部皮质类固醇和或不使用局部钙调神经磷酸酶抑制剂）。。

The trials were conducted in adolescent and adult patients (12 years and over) with moderate-to-severe atopic dermatitis for an initial treatment phase of 16 weeks. Patients who responded to treatment (defined as patients who achieved an investigator’s global assessment score of clear (0) or almost clear (1), or a 75% or greater improvement in the eczema area and severity index score) were then re-randomized to a maintenance treatment phase for up to 48 weeks..

这些试验是在青少年和成年患者（12岁及以上）中进行的，患有中度至重度特应性皮炎，初始治疗阶段为16周。对治疗有反应的患者（定义为研究者的总体评估评分为清晰（0）或几乎清晰（1），或湿疹面积和严重程度指数评分改善75%或更高的患者）被重新随机分配到维持治疗阶段长达48周。。

About atopic dermatitis

关于特应性皮炎

Atopic dermatitis

特应性皮炎

is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions.

是一种常见的慢性炎症性皮肤病，以持续性瘙痒和反复发作的皮损为特征。

It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis.

它是最常见的炎症性皮肤病，影响的人数几乎是牛皮癣的四倍。

It affects approximately 10 to 40 million people in the European Union, with up to 66% of adults suffering with a moderate-to-severe form of the condition.

它影响了欧盟大约1000万至4000万人，高达66%的成年人患有中度至重度疾病。

While currently available treatments may improve some signs and symptoms of the disease, many patients do not respond optimally to approved therapies and do not experience itch relief and clear skin to the same degree.

虽然目前可用的治疗方法可以改善该病的一些症状和体征，但许多患者对已获批准的治疗方法的反应并不理想，也无法获得相同程度的瘙痒缓解和皮肤通透感。

About the OLYMPIA clinical trial program

关于奥林匹亚临床试验计划

The OLYMPIA program included two identically designed, pivotal phase III clinical trials which enrolled 560 patients – OLYMPIA 1 and OLYMPIA 2. This is the largest clinical trial program conducted in prurigo nodularis to date, and the only program to include a long-term extension study.

奥林匹亚计划包括两项设计相同的关键III期临床试验，共招募了560名患者-奥林匹亚1号和奥林匹亚2号。这是迄今为止在结节性痒疹中进行的最大的临床试验项目，也是唯一包括长期延伸研究的项目。

These global, randomized, double-blind, placebo-controlled phase III clinical trials assessed the efficacy and safety of nemolizumab monotherapy compared with placebo in patients at least 18 years of age with moderate-to-severe prurigo nodularis over a 16- or 24-week treatment period for OLYMPIA 2 and OLYMPIA 1, respectively..

这些全球性，随机，双盲，安慰剂对照的III期临床试验评估了奈莫珠单抗单药治疗与安慰剂相比在16周或24周治疗期间至少18岁中度至重度结节性痒疹患者的疗效和安全性。奥林匹亚2号和奥林匹亚1号。。

About prurigo nodularis

关于结节性痒疹

Prurigo nodularis

结节性痒疹

is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas.

是一种慢性，衰弱且独特的神经免疫性皮肤病，其特征是存在强烈的瘙痒和覆盖大面积的厚皮肤结节。

It is estimated to affect between 7-111 people per 100,000 in the European Union depending on the country.

据估计，在欧盟，每10万人中就有7-111人受到影响，具体取决于国家。

The majority of patients report that the persistent itch negatively impacts their quality of life.

大多数患者报告说，持续性瘙痒会对他们的生活质量产生负面影响。

Furthermore, the intense itch associated with prurigo nodularis results in significant sleep disturbance and further contributes to reduced quality of life.

此外，与结节性痒疹相关的强烈瘙痒会导致严重的睡眠障碍，并进一步导致生活质量下降。

About Galderma

关于Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology.

Galderma（六：GALD）是纯粹的皮肤病学类别的领导者，目前在大约90个国家/地区。我们通过注射美学、皮肤科皮肤护理和治疗性皮肤病学，提供创新、科学的优质旗舰品牌和服务组合，涵盖快速增长的皮肤病学市场的所有领域。

Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story.

自1981年成立以来，我们一直专注于人体最大的器官-皮肤-与医疗保健专业人员合作，以优异的效果满足个人消费者和患者的需求。因为我们了解我们所处的皮肤塑造了我们的生活，所以我们正在为每一个皮肤故事推进皮肤病学。