LEO Pharma A/S, a global leader in medical dermatology, today announced that Swissmedic, Switzerland’s national regulatory agency for approving and overseeing therapeutic products, has granted marketing approval for Anzupgo® (delgocitinib) cream. The indication is for the treatment of moderate to severe Chronic Hand Eczema (CHE) in adults who have had an inadequate response to topical corticosteroids, or for whom potent to very potent topical corticosteroids are not advisable.1.

LEO Pharma A/S是一家全球皮肤科医学领导者，今天宣布瑞士国家监管机构Swissmedic批准和监督治疗产品，已批准Anzupgo®（delgocitinib）乳膏上市。该适应症用于治疗对局部皮质类固醇反应不足的成年人的中度至重度慢性手部湿疹（CHE），或者不建议使用强效至非常强效的局部皮质类固醇。

Anzupgo is the first topical pan-Janus kinase (JAK) inhibitor to be approved in Switzerland specifically for moderate to severe CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.1,8

Anzupgo是瑞士第一种专门针对中度至重度CHE批准的局部泛Janus激酶（JAK）抑制剂。它抑制JAK-STAT信号的激活，JAK-STAT信号在CHE的发病机制中起关键作用。1,8

“With the Swissmedic approval of Anzupgo, we mark yet another critical regulatory milestone in our effort to advance the standard of CHE care and to bring this treatment to as many patients as possible,” said Becki Morison, Executive Vice President, Global Product Strategy & International Operations for LEO Pharma.

LEO Pharma全球产品战略和国际运营执行副总裁贝基·莫里森（Becki Morison）表示：“随着瑞士医学会（Swissmedic）对安祖普（Anzupgo）的批准，我们标志着我们努力提高CHE护理标准并尽可能多地将这种治疗方法带给更多患者的又一个关键监管里程碑。”。

“This approval means Anzupgo is the first pan-JAK inhibitor approved for CHE in Switzerland and this highlights LEO Pharma’s unique strength in innovative topicals. We are incredibly excited to introduce a new topical treatment option to adult Swiss patients living with this debilitating disease as soon as possible.'.

“这一批准意味着Anzupgo是瑞士第一个批准用于CHE的泛JAK抑制剂，这突显了LEO Pharma在创新性局部用药方面的独特优势。我们非常高兴能尽快为患有这种衰弱性疾病的瑞士成年患者推出一种新的局部治疗选择。”。

Head-to-head trial with systemic alternative included in Swiss label

瑞士标签中包含系统替代品的头对头试验

In line with the approval in the European Union, the marketing approval of Anzupgo in Switzerland is based on the results from the phase 3 program, which includes the DELTA 1, 2 and 3 clinical trials that evaluated the safety and efficacy of Anzupgo compared to cream vehicle.4-6,9

根据欧盟的批准，Anzupgo在瑞士的上市批准是基于第三阶段计划的结果，其中包括评估Anzupgo与乳膏载体相比的安全性和有效性的DELTA 1、2和3临床试验。4-6,9

In addition, the Swiss approval is supported by the results from the head-to-head DELTA FORCE phase 3 clinical trial, which evaluated the efficacy and safety of Anzupgo compared with oral alitretinoin capsules.10 Alongside Anzupgo, alitretinoin is the only other treatment currently approved in Switzerland to specifically treat severe CHE in patients who do not respond to topical corticosteroids.1,11,12.

此外，瑞士的批准得到了头对头DELTA FORCE 3期临床试验结果的支持，该试验评估了Anzupgo与口服阿利维甲酸胶囊相比的疗效和安全性.10与Anzupgo一起，阿利维甲酸是目前瑞士唯一批准的其他治疗方法，专门治疗对局部皮质类固醇无反应的患者的严重CHE[1,11,12]。

“Introducing the first pan-JAK inhibitor for adult Swiss patients living with CHE in the coming months is a proud moment for us. The approval of Anzupgo was supported by compelling scientific evidence, including a head-to-head comparison with the current standard of care,” said Florian Muschaweck, General Manager, LEO Pharma Switzerland and Austria.

瑞士利奥制药公司（LEO Pharma Switzerland）和奥地利（Austria）总经理弗洛里安·马斯切维克（Florian Muschaweck）表示：“在未来几个月为瑞士成年CHE患者推出第一种泛JAK抑制剂，对我们来说是一个引以为豪的时刻。Anzupgo的批准得到了令人信服的科学证据的支持，包括与当前护理标准的正面比较。”。

'CHE can affect far more than just your skin – including your mental health, your social life and your opportunities to take care of your work or your family. We are excited to be able to offer a new treatment option to adult Swiss patients living with this disease.'.

“CHE不仅会影响你的皮肤，还会影响你的心理健康、社交生活以及照顾工作或家庭的机会。我们很高兴能够为患有这种疾病的瑞士成年患者提供新的治疗选择。”。

Swissmedic’s decision follows the recent European Union approval of Anzupgo which is valid in all European Member States, Iceland, Norway, and Liechtenstein.9 Regulatory filings in other markets are underway.

瑞士医学院（Swissmedic）的决定是在欧盟最近批准Anzupgo之后做出的，该批准在所有欧洲成员国、冰岛、挪威和列支敦士登均有效。9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 Anzupgo compared with cream vehicle in the treatment of adults with moderate to severe CHE.13-15

随机，双盲，媒介物对照，多中心3期临床试验（DELTA 1和DELTA 2）的主要目的是评估每日两次应用Anzupgo与乳膏媒介物治疗成人中度至重度CHE.13-15的疗效

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).13-15.

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的全球评估（IGA-CHE TS）。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。额外的IGA-CHE评分包括2（轻度），3（中度）和4（重度）.13-15。

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）从基线至少改善75%，从基线至少改善90%。

The number of treatment-emergent adverse events from baseline to Week 16 defined the key safety endpoint of the trials.13-15.

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.13-15。

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

在试验DELTA 1或DELTA 2中，每天两次用Anzupgo或乳膏载体完成16周治疗的受试者被提供转入DELTA 3开放标签，多部位延伸试验。这项延期试验的目的是评估Anzupgo的长期安全性

About the DELTA FORCE Trial

关于DELTA FORCE审判

DELTA FORCE was a 24-week, randomized, assessor-blinded, active-controlled, parallel-group, phase 3, two-arm trial to compare the efficacy and safety of delgocitinib cream twice-daily with oral alitretinoin capsules once-daily in adult participants with severe chronic hand eczema.10

DELTA FORCE是一项为期24周的随机，评估者盲法，主动对照，平行组，第3阶段，双臂试验，比较delgocitinib乳膏每日两次与口服阿利维a酸胶囊每日一次在成人严重慢性手部湿疹患者中的疗效和安全性

The primary endpoint of the trial was the change in Hand Eczema Severity Index (HECSI) score from baseline to Week 12. Participants assigned to receive delgocitinib cream applied the drug to the skin twice a day for 16 weeks. Participants assigned to receive alitretinoin capsules took the drug orally once a day for 12 weeks.

试验的主要终点是手部湿疹严重程度指数（HECSI）评分从基线到第12周的变化。被分配接受delgocitinib乳膏的参与者每天两次将药物涂抹在皮肤上，持续16周。被分配接受阿利维a酸胶囊治疗的参与者每天口服一次该药物，持续12周。

All participants were permitted to continue for up to 24 weeks if the doctor considered that they were benefiting from the treatment.10.

如果医生认为他们从治疗中受益，所有参与者都被允许继续长达24周。

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.12,17 CHE is one of the most common skin disorders of the hands, with a prevalence rate of approximately 4.7%.3 In a substantial number of patients, HE can develop into a chronic condition.18 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.11.

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）[12,17]。CHE是手部最常见的皮肤病之一，患病率约为4.7%[3]。在相当多的患者中，他可能会发展为慢性病[18]。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等症状。

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,19 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.20 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.21.

CHE已被证明会造成影响患者生活质量的心理和功能负担[19]，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[20]。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® （delgocitinib）乳膏

Anzupgo® (delgocitinib) cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE. It inhibits the activation of JAK-STAT signalling, which plays a key role in the pathogenesis of CHE.18 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.11 Anzupgo is currently approved in the European Union and Switzerland for the treatment of moderate to severe CHE in adults for whom topical corticosteroids are inadequate or inappropriate.

Anzupgo®（delgocitinib）乳膏是一种局部泛Janus激酶（JAK）抑制剂，用于治疗中度至重度CHE。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.18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.11 Anzupgo目前已被欧盟和瑞士批准用于治疗局部皮质类固醇不足或不合适的成年人的中度至重度CHE。

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.

LEO Pharma是一家全球性公司，致力于提高护理标准，为皮肤病患者及其家人和社会造福。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 4,000 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion..

LEO Pharma总部位于丹麦，拥有4000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。。