MADISON, N.J.--(BUSINESS WIRE)--LEO Pharma Inc. announced today the availability of the Adbry® (tralokinumab-ldrm) 300 mg/2 mL single-dose autoinjector in the United States. Adbry is currently indicated in the U.S. for patients 12 years and older with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.1.

新泽西州麦迪逊市——（商业新闻短讯）——LEO Pharma Inc.今天宣布在美国推出Adbry®（tralokinumab ldrm）300 mg/2 mL单剂量自动注射器。Adbry目前在美国适用于12岁及以上患有中度至重度特应性皮炎（AD）的患者，这些患者的疾病不能通过局部处方疗法得到充分控制，或者这些疗法不可取。

Prior to the introduction of the autoinjector device, Adbry was only available in a 150mg/1mL pre-filled syringe. With the new 300 mg/2 mL autoinjector device, adult patients now have another convenient option and half the number of required injections compared to the 150 mg/1 mL pre-filled syringe.1.

在引入自动注射器设备之前，Adbry仅在150mg/1mL预填充注射器中可用。使用新的300 mg/2 mL自动注射器装置，成年患者现在有了另一个方便的选择，与150 mg/1 mL预充注射器相比，所需的注射次数减少了一半。

“I understand from discussions with my patients that living with AD already brings a wide range of difficulties and debilitating factors that need to be managed on a daily basis, so it is integral that any treatment solution is more convenient to manage for those living with the condition, and does not add even more of a burden,” said Jonathan Silverberg, M.D., Ph.D., Professor of Dermatology, of George Washington University.

乔治华盛顿大学（GeorgeWashington University）皮肤病学教授乔纳森·西尔弗伯格（JonathanSilverberg）医学博士说：“我从与患者的讨论中了解到，患有AD已经带来了各种各样的困难和衰弱因素，需要每天进行管理，因此任何治疗方案都可以为患有AD的患者提供更方便的管理，并且不会增加更多的负担。”。

“This new administration option reduces the number of injections required overall and provides adults living with AD with an additional option in how they manage their condition.”.

“这种新的给药选择减少了总体所需的注射次数，并为患有AD的成年人提供了如何管理病情的额外选择。”。

For patients who prefer the pre-filled syringe, this option will continue to be available in the U.S. for both adults and pediatric patients (age 12-17).

对于喜欢预填充注射器的患者，美国将继续为成人和儿科患者（12-17岁）提供此选项。

“We are proud to expand the administration options for Adbry and the choices available for those adults who are living with AD,” said Brian Hilberdink EVP and President, Region North America, LEO Pharma. “Today’s news supports our goal to help improve the standard of care for those living with skin diseases and highlights our commitment to innovation.

。“今天的新闻支持了我们的目标，即帮助改善皮肤病患者的护理水平，并强调了我们对创新的承诺。

We will continue to work tirelessly to improve the treatment options available for various skin conditions in the U.S.”.

我们将继续不懈努力，改进美国各种皮肤病的治疗方案。”。

In the U.S., Adbry is available in a 150 mg/1 mL single-use pre-filled syringe as well as a 300 mg/2 mL single-use autoinjector. For adults, Adbry is administered with an initial loading dose of 600 mg (four injections with prefilled syringe or two injections with autoinjector) followed by a maintenance dose of 300 mg dose every two weeks (two injections with prefilled syringe or one injection with the autoinjector).

在美国，Adbry可用于150 mg/1 mL一次性预充注射器以及300 mg/2 mL一次性自动注射器。对于成人，Adbry的初始负荷剂量为600 mg（使用预填充注射器进行四次注射或使用自动注射器进行两次注射），然后每两周维持300 mg剂量（使用预填充注射器进行两次注射或使用自动注射器进行一次注射）。

Adbry adult patients have the flexibility to take a single monthly dose (300 mg/2 mL every 4 weeks) for those who achieve clear or almost clear skin after 16 weeks and weigh<220 pounds..

Adbry成年患者可以灵活地每月服用一次剂量（每4周服用300毫克/2毫升），对于那些在16周后达到透明或几乎透明皮肤且体重小于220磅的患者。。

Adbry (tralokinumab-ldrm) is marketed outside of the U.S. under the tradename Adtralza® (tralokinumab) and is approved for the treatment of adults and pediatric patients (12 years and above) with moderate-to- severe AD in the U.S., Canada, the European Union, the United Arab Emirates, Great Britain, Saudi Arabia and South Korea.

Adbry（tralokinumab ldrm）在美国境外以商品名Adtralza®（tralokinumab）销售，并在美国，加拿大，欧盟，阿拉伯联合酋长国，英国，沙特阿拉伯和韩国被批准用于治疗中度至重度AD的成人和儿科患者（12岁及以上）。

Adtralza is approved for use in adults with moderate-to-severe AD in Switzerland, and Japan..

Adtralza在瑞士和日本被批准用于患有中度至重度AD的成年人。。

About atopic dermatitis

关于特应性皮炎

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.3,4 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.5 Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.6.

特应性皮炎是一种慢性炎症性皮肤病，其特征是强烈的瘙痒和湿疹性病变[3,4]。特应性皮炎是皮肤屏障功能障碍和免疫失调的结果，导致慢性炎症[5]。包括IL-13在内的2型细胞因子在特应性皮炎病理生理学的关键方面发挥重要作用。

About Adbry® (tralokinumab-ldrm)

关于Adbry® （曲洛金单抗ldrm）

Adbry® (tralokinumab-ldrm), which is marketed outside of the U.S. under the tradename Adtralza® (tralokinumab), is a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.5 Adbry® specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).3.

Adbry®（tralokinumab ldrm）在美国境外以商品名Adtralza®（tralokinumab）销售，是一种高亲和力的全人单克隆抗体，开发用于结合和抑制白细胞介素（IL）-13细胞因子，在特应性皮炎体征和症状的免疫和炎症过程中发挥作用[5]。Adbry®特异性结合IL-13细胞因子，从而抑制与IL-13受体α1和α2亚基（IL-13Rα1和IL-13Rα2）的相互作用。

INDICATION AND IMPORTANT SAFETY INFORMATION

指示和重要安全信息

What is ADBRY?

ADBRY是什么？

ADBRY® (tralokinumab-ldrm) injection is a prescription medicine used to treat people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. ADBRY can be used with or without topical corticosteroids..

ADBRY®（tralokinumab ldrm）注射液是一种处方药，用于治疗12岁及以上患有中度至重度特应性皮炎（湿疹）的患者，这些患者的皮肤处方疗法（局部）控制不佳，或者无法使用局部疗法。ADBRY可以与或不与局部皮质类固醇一起使用。。

It is not known if ADBRY is safe and effective in children under 12 years of age.

目前尚不清楚ADBRY对12岁以下儿童是否安全有效。

Do not use ADBRY if you are allergic to tralokinumab or to any of its ingredients.

。

What should I discuss with my healthcare provider before starting ADBRY?

在开始ADBRY之前，我应该与我的医疗保健提供者讨论什么？

Tell your healthcare provider about all your medical conditions, including if you:

告诉您的医疗保健提供者您的所有医疗状况，包括您是否：

have eye problems.

眼睛有问题。

have a parasitic (helminth) infection.

有寄生虫感染。

are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with ADBRY.

计划接种任何疫苗。如果你接受ADBRY治疗，你不应该接种“活疫苗”。

are pregnant or plan to become pregnant. It is not known whether ADBRY will harm your unborn baby. There is a pregnancy exposure registry for women who use ADBRY during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. You or your healthcare provider can get information and enroll you in this registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/..

怀孕或计划怀孕。目前尚不清楚阿德布里是否会伤害您的未出生婴儿。对于怀孕期间使用ADBRY的女性，有一个怀孕暴露登记处。此注册表的目的是收集有关您和您的宝宝健康的信息。您或您的医疗保健提供者可以通过拨打1-877-311-8972或访问https://mothertobaby.org/ongoing-study/adbry-tralokinumab/..

are breastfeeding or plan to breastfeed. It is not known whether ADBRY passes into your breast milk and if it can harm your baby.

正在母乳喂养或计划母乳喂养。目前尚不清楚ADBRY是否会进入您的母乳，以及它是否会伤害您的宝宝。

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

告诉你的医疗保健提供者你服用的所有药物，包括处方药和非处方药、维生素和草药补充剂。

How should I use ADBRY?

我应该如何使用ADBRY？

See the detailed “Instructions for Use” that comes with ADBRY for information on how to prepare and inject ADBRY and how to properly store and throw away (dispose of) used ADBRY prefilled syringes and autoinjectors.

有关如何准备和注射ADBRY以及如何正确储存和丢弃（处置）使用过的ADBRY预充注射器和自动注射器的信息，请参阅ADBRY随附的详细“使用说明”。

Use ADBRY exactly as prescribed by your healthcare provider.

严格按照医疗保健提供者的规定使用ADBRY。

Your healthcare provider will tell you how much ADBRY to inject and when to inject it.

你的医疗保健提供者会告诉你注射多少ADBRY以及何时注射。

ADBRY comes as a single-dose prefilled syringe with needle guard or as an autoinjector.

ADBRY是一种带有针头防护装置的单剂量预填充注射器或自动注射器。

ADBRY is given as an injection under the skin (subcutaneous injection).

ADBRY作为皮下注射（皮下注射）给予。

If your healthcare provider decides that you or a caregiver can give the injections of ADBRY, you or your caregiver should receive training on the right way to prepare and inject ADBRY. Do not try to inject ADBRY until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that ADBRY be given by or under supervision of an adult..

如果您的医疗保健提供者决定您或护理人员可以注射ADBRY，则您或您的护理人员应接受正确制备和注射ADBRY方法的培训。在医疗保健提供者向您展示正确方法之前，不要尝试注射ADBRY。对于12岁及以上的儿童，建议由成年人或在成年人的监督下进行ADBRY。。

If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.

如果您错过了一剂，请尽快注射错过的剂量，然后在您的常规计划时间继续服用下一剂。

If you inject too much ADBRY than prescribed, call your healthcare provider or call Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

如果您注射的ADBRY超过规定量，请致电您的医疗保健提供者或致电毒物帮助热线1-800-222-1222，或立即前往最近的医院急诊室。

Your healthcare provider may prescribe other medicines to use with ADBRY. Use the other prescribed medicines exactly as your healthcare provider tells you to.

您的医疗保健提供者可能会开其他药物与ADBRY一起使用。请严格按照医疗保健提供者的指示使用其他处方药物。

What are the possible side effects of ADBRY?

？

ADBRY can cause serious side effects including:

ADBRY可引起严重的副作用，包括：

Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:

过敏反应（超敏反应），包括称为过敏反应的严重反应。

breathing problems

呼吸问题

itching

瘙痒

skin rash

皮疹

swelling of the face, mouth, and tongue

面部、口腔和舌头肿胀

fainting, dizziness, feeling lightheaded (low blood pressure)

昏厥、头晕、头晕（低血压）

hives

Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.

眼睛问题。如果您有任何新的或恶化的眼部问题，包括眼部疼痛或视力改变，请告诉您的医疗保健提供者。

The most common side effects of ADBRY include:

ADBRY最常见的副作用包括：

upper respiratory tract infections

上呼吸道感染

Eye and eyelid inflammation, including redness, swelling, and itching

眼睛和眼睑发炎，包括发红、肿胀和瘙痒

Injection site reactions

注射部位反应

High count of a certain white blood cell (eosinophilia)

某种白细胞计数高（嗜酸性粒细胞增多）

These are not all the possible side effects of ADBRY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

这些并不是ADBRY可能产生的所有副作用。请致电您的医生寻求有关副作用的医学建议。您可以通过1-800-FDA-1088向FDA报告副作用。

Please click here for full U.S. Prescribing Information, including Patient Information and Instructions for Use.

请单击此处获取完整的美国处方信息，包括患者信息和使用说明。

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。利奥制药成立于1908年，主要由利奥基金会所有，几十年来一直致力于研究和开发，以推动皮肤病学的发展，今天，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

Adbry® (tralokinumab-ldrm) Prescribing Information. LEO Pharma; June 2024.

还原® （tralokinumab ldrm）处方信息。利奥制药；2024年6月。

Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. Atopic Dermatitis in America Study: A Cross- Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population. J Invest Dermatol. 2019;139(3):583-590.

Chiesa Fuxench ZC，Block JK，Boguniewicz M等。美国特应性皮炎研究：一项横断面研究，研究美国成年人群特应性皮炎的患病率和疾病负担。J投资皮肤病。2019年；139（3）：583-590。

Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017; 429:208- 19.

Popovic B等人。结构表征揭示了IL-13中和单克隆抗体tralokinumab抑制与IL-13Rα1和IL-13Rα2结合的机制。J摩尔生物学。2017年；429:208-19。

Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109-1122.

Weidinger S，Novak N.特应性皮炎。柳叶刀。2016年；387（10023）：1109-1122。

Boguniewicz M, Leung DY. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-246.

Boguniewicz M，Leung DY.特应性皮炎：一种皮肤屏障改变和免疫失调的疾病。Immunol Rev.2011；242（1）：233-246。

Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.

Bieber T.白细胞介素-13：针对特应性皮炎中被低估的细胞因子。过敏。2020；75:54-62。

MAT-76307 September 2024

MAT-76307 2024年9月