BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion that recommends the approval of Anzupgo® (delgocitinib cream) for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate..

丹麦巴勒鲁普——（商业新闻短讯）——全球医学皮肤病学领导者利奥制药公司（LEO Pharma A/S）今天宣布，欧洲药品管理局（EMA）人类使用药品委员会（CHMP）已采取积极的意见，建议批准Anzupgo®（delgocitinib乳膏）用于治疗成人中度至重度慢性手部湿疹（CHE），对于这些患者，外用皮质类固醇不足或不合适。。

Delgocitinib cream is an investigational topical pan-JAK inhibitor for CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.5 Currently, there are no topical treatments specifically approved for adults with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate..

Delgocitinib乳膏是一种用于CHE的研究性局部泛JAK抑制剂。它抑制JAK-STAT信号的激活，JAK-STAT信号在CHE的发病机制中起着关键作用。目前，没有专门针对局部皮质类固醇不足或不合适的中度至重度CHE成人的局部治疗方法。。

CHE is a heterogeneous, fluctuating, inflammatory skin disease with key symptoms of itch and pain. Its pathophysiology is characterized by skin barrier dysfunction, skin inflammation, and skin microbiome alterations.6 The condition has been proven to have a high psychological, social, and occupational burden.7,8,9.

CHE是一种异质性，波动性，炎症性皮肤病，主要症状为瘙痒和疼痛。其病理生理学特征是皮肤屏障功能障碍，皮肤炎症和皮肤微生物组改变[6]。该病已被证明具有较高的心理，社会和职业负担[7,8,9]。

“It is well known that CHE is challenging to live with and manage, potentially impacting personal relationships and careers,” said Christophe Bourdon, Chief Executive Officer, LEO Pharma. “Despite the considerable burden of the condition, treatments options approved for CHE have been limited. As an organization, we are dedicated to helping advance the standard of care for the benefit of people with skin conditions, and today we are one step closer to addressing the unmet need that may be faced by those living with CHE.”.

LEO Pharma首席执行官克里斯托夫·波登（ChristopheBourdon）表示：“众所周知，CHE在生活和管理方面具有挑战性，可能会影响个人关系和职业生涯。”。。

The positive CHMP opinion for delgocitinib cream is based on results from the phase 3 program, which includes the DELTA 1 and DELTA 2 clinical trials that evaluated the safety and efficacy of delgocitinib cream compared to cream vehicle.1,2,3 Both trials met their primary and all secondary endpoints.10,11 Subjects who completed the 16-week DELTA 1 or DELTA 2 trials were immediately offered to enroll in the 36-week DELTA 3 open-label extension trial.4 Results demonstrated a long-term safety profile consistent with previous trial results.12.

delgocitinib乳膏的阳性CHMP意见是基于第三阶段计划的结果，其中包括DELTA 1和DELTA 2临床试验，这些试验评估了delgocitinib乳膏与乳膏载体相比的安全性和有效性[1,2,3]。两项试验均符合其主要和所有次要终点[10,11]。完成16周DELTA 1或DELTA 2试验的受试者立即被提供参加36周DELTA 3开放标签延长试验[4]。结果显示长期安全性与之前的试验结果一致。

“The practical and highly visible location of CHE brings a considerable burden,” said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. “Our hands are integral to every aspect of our day to day lives, so avoiding physical triggers can be challenging for people living with CHE. At the same time, the highly visible area of this condition can have a negative impact psychologically and emotionally.

LEO Pharma首席开发官Kreesten Meldgaard Madsen说：“CHE的实际位置和高度可见的位置带来了相当大的负担。”。“我们的手对于我们日常生活的各个方面都是不可或缺的，因此避免身体触发对于患有CHE的人来说可能是一项挑战。同时，这种情况的高度可见区域可能会对心理和情绪产生负面影响。

I am incredibly proud of this milestone and we will now continue our work to support those living with CHE.”.

我为这一里程碑感到无比骄傲，我们现在将继续努力，支持那些与CHE生活在一起的人。”。

The CHMP’s positive opinion will be reviewed by the European Commission (EC) and, pending the final decision, authorization of delgocitinib cream will be valid in all EU member states, Iceland, Norway, and Liechtenstein. Regulatory filings in other markets are underway.

CHMP的积极意见将由欧盟委员会（EC）审查，在最终决定之前，delgocitinib乳膏的授权将在所有欧盟成员国，冰岛，挪威和列支敦士登有效。其他市场的监管备案正在进行中。

About the DELTA 1, 2 and 3 Trials

关于DELTA 1、2和3试验

The primary objective for the randomized, double-blind, vehicle-controlled, multi-center phase 3 clinical trials (DELTA 1 and DELTA 2) was to evaluate the efficacy of twice-daily applications of delgocitinib cream compared with cream vehicle in the treatment of adults with moderate to severe CHE.1,2,3.

。

The primary endpoint of the trials was the Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at Week 16. Treatment success was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline. Additional IGA-CHE scores included 2 (mild), 3 (moderate), and 4 (severe).1,2,3.

试验的主要终点是研究者在第16周对慢性手部湿疹治疗成功率（IGA-CHE TS）的全球评估。治疗成功被定义为IGA-CHE评分为0（清晰）或1（几乎清晰），与基线相比至少有两步改善。其他IGA-CHE评分包括2（轻度），3（中度）和4（重度）.1,2,3。

Key secondary endpoints at Week 16 included reduction of itch and pain scores of ≥4 points measured by the Hand Eczema Symptom Diary (HESD) from baseline to Week 16, as well as at least 75% improvement from baseline and at least 90% improvement from baseline on the Hand Eczema Severity Index (HECSI) at Week 16.

第16周的关键次要终点包括从基线到第16周，手部湿疹症状日记（HESD）测量的瘙痒和疼痛评分降低≥4分，以及第16周手部湿疹严重程度指数（HECSI）比基线至少改善75%，比基线至少改善90%。

The number of treatment-emergent adverse events from baseline to Week 16 defined the key safety endpoint of the trials.1,2,3.

从基线到第16周的治疗紧急不良事件的数量确定了试验的关键安全终点[1,2,3]。

Subjects who completed 16 weeks of treatment with delgocitinib cream or cream vehicle twice daily in trials DELTA 1 or DELTA 2 were offered to roll-over to the 36-week DELTA 3 Open-label, Multi-site Extension trial. The purpose of this extension trial was to evaluate the long-term safety of delgocitinib.4.

在DELTA 1或DELTA 2试验中，每天两次用delgocitinib乳膏或乳膏载体完成16周治疗的受试者被提供转入36周的DELTA 3开放标签多部位延长试验。该扩展试验的目的是评估delgocitinib的长期安全性。

About Chronic Hand Eczema

关于慢性手部湿疹

Chronic hand eczema (CHE) is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year.13,14 HE is the most common skin disorder of the hands15 with a one-year prevalence rate of approximately 9%.16 In a substantial number of patients, HE can develop into a chronic condition.15 CHE is a fluctuating disorder characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.7.

慢性手部湿疹（CHE）被定义为持续三个月以上或一年内复发两次或两次以上的手部湿疹（HE）[13,14]。他是手部最常见的皮肤病[15]，一年患病率约为9%[16]。在相当多的患者中，他可以发展为慢性病[15]。CHE是一种以瘙痒和疼痛为特征的波动性疾病，患者可能会出现红斑，鳞屑，苔藓化，角化过度，水泡，水肿以及手和手腕上的裂缝。

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,8 with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition.17 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.18.

CHE已被证明会造成影响患者生活质量的心理和功能负担[8]，大约70%患有严重CHE的人承认在日常活动中存在问题，并且由于这种情况而在日常生活中受到干扰[17]。此外，职业和收入潜力也被证明受到与CHE一起生活的负担的影响。

About Anzupgo® (delgocitinib cream)

关于Anzupgo® （德尔戈西尼乳膏）

Anzupgo® (delgocitinib cream) is an investigational topical pan-Janus kinase (JAK) inhibitor for moderate to severe CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.4 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.5 LEO Pharma is currently developing delgocitinib cream formulation for the treatment of moderate to severe chronic hand eczema (CHE) in adults, which is currently not approved by any health authority.

Anzupgo®（delgocitinib乳膏）是一种用于中重度CHE的研究性局部泛Janus激酶（JAK）抑制剂。它抑制JAK-STAT信号的激活，JAK-STAT信号在CHE的发病机制中起着关键作用。病理生理学的特征是皮肤屏障功能障碍，皮肤炎症和皮肤微生物组的改变。LEO Pharma目前正在开发用于治疗成人中重度慢性手部湿疹（CHE）的delgocitinib乳膏制剂，目前尚未得到任何卫生当局的批准。

In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib cream for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights..

2014年，LEO Pharma A/S和日本烟草公司（JT）签订了一项许可协议，LEO Pharma获得了独家开发和商业化delgocitinib乳膏的权利，用于全球皮肤科适应症的局部使用，日本除外，JT保留权利。。

About LEO Pharma

关于LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities.

利奥制药（LEO Pharma）是一家全球性公司，致力于提高护理标准，造福皮肤病患者及其家人和社会。LEO Pharma成立于1908年，由LEO基金会拥有多数股权。LEO Pharma致力于数十年的研究和开发，以推动皮肤病学的发展。如今，该公司为所有严重疾病提供了广泛的治疗方法。

LEO Pharma is headquartered in Denmark with a global team of 4,200 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion..

利奥制药（LEO Pharma）总部位于丹麦，拥有4200人的全球团队，为全球数百万患者提供服务。2023年，该公司净销售额为114亿丹麦克朗。。

References

参考文献

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MAT-75246 July 2024

MAT-75246 2024年7月