First new intravenous (IV) treatment option in six years for adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)1-6

成人银屑病关节炎（PsA），强直性脊柱炎（AS）和非放射性轴性脊柱关节炎（nr-axSpA）1-6的六年内首次新的静脉内（IV）治疗选择

Cosentyx® (secukinumab) administered via IV infusion offers healthcare providers choice and flexibility to tailor treatment to their patients' unique needs

通过静脉输注给药的Cosentyx®（苏金单抗）为医疗保健提供者提供选择和灵活性，以根据患者的独特需求量身定制治疗方案

With both IV and subcutaneous formulations, Cosentyx can now help a broader range of PsA, AS and nr-axSpA patients manage their condition

通过IV和皮下制剂，Cosentyx现在可以帮助更广泛的PsA，AS和nr-axSpA患者管理他们的病情

EAST HANOVER, N.J., Oct. 6, 2023 /PRNewswire/ -- Novartis, a global leader in immuno-dermatology and rheumatology, announced today that the US Food and Drug Administration (FDA) has approved an intravenous (IV) formulation of Cosentyx® (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).

新泽西州东汉诺威市，2023年10月6日/PRNewswire/-诺华公司是免疫皮肤病学和风湿病学的全球领导者，今天宣布美国食品和药物管理局（FDA）已批准静脉注射（IV）Cosentyx®（苏金单抗）用于治疗银屑病关节炎（PsA），强直性脊柱炎（AS）和非放射性轴性脊柱关节炎（nr-axSpA）的成人。

Cosentyx is the only treatment approved in an IV formulation that specifically targets and blocks interleukin-17A (IL-17A), and the only non-tumor necrosis factor alpha (TNF-α) IV option available in all these indications. The IV formulation of Cosentyx offers patients a monthly 30-minute, weight-based dosing option, requiring no pre-medication and no lab monitoring.1 The new IV administration option will be available in Q4 of 2023..

Cosentyx是IV制剂中唯一批准的特异性靶向和阻断白细胞介素-17A（IL-17A）的治疗方法，也是所有这些适应症中唯一可用的非肿瘤坏死因子α（TNF-α）IV选项。Cosentyx的IV配方为患者提供每月30分钟的基于体重的剂量选择，无需预先服药和无实验室监测.1新的IV管理选项将于2023年第四季度推出。。

'A significant portion of the millions of PsA, AS and nr-axSpA patients in the US require treatment through IV infusions for a variety of reasons, including not being comfortable with self-injections or simply preferring to have treatments administered in their healthcare provider's office,' said Philip J.

“美国数百万PsA，AS和nr-axSpA患者中有相当一部分需要通过静脉输注进行治疗，原因多种多样，包括对自我注射不舒服或仅仅喜欢在其医疗保健提供者办公室接受治疗，'菲利普J。

Mease, M.D., Clinical Professor at the University of Washington School of Medicine and Director of Rheumatology Research at the Swedish Medical Center in Seattle, WA. 'The approval of Cosentyx as an IV formulation is an important milestone for patients because it expands the treatment options available to them with a different mechanism of action than existing biologic IV therapies, along with the comfort and familiarity of an established treatment.'.

Mease，医学博士，华盛顿大学医学院临床教授，华盛顿州西雅图瑞典医学中心风湿病研究主任Cosentyx作为静脉注射制剂的批准是患者的一个重要里程碑，因为它扩大了他们可用的治疗方案，其作用机制与现有的生物IV疗法不同，并且对已建立的治疗方法感到舒适和熟悉。

'At Novartis, we are committed to ensuring healthcare providers and patients have treatment options available to meet their unique needs. With this approval of Cosentyx as an IV formulation, along with the subcutaneous formulation, we can broaden the use of Cosentyx to help more patients manage their condition with a medicine backed by more than a decade of clinical research and eight years of real-world experience,' said Christy Siegel, Vice President and Head of Immunology, Novartis US..

“在诺华，我们致力于确保医疗保健提供者和患者有治疗选择来满足他们的独特需求。随着Cosentyx作为静脉注射制剂和皮下制剂的批准，我们可以扩大Cosentyx的使用范围，帮助更多患者使用十多年临床研究和八年实际经验支持的药物来控制病情美国诺华免疫学副总裁兼主管克里斯蒂·西格尔说。。

About Cosentyx® (secukinumab)  Cosentyx is a fully human biologic that specifically targets and blocks interleukin-17A (IL-17A), an important cytokine involved in the inflammation of psoriatic arthritis (PsA), moderate to severe plaque psoriasis, ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).7,8 Cosentyx is a proven medicine and has been studied clinically for more than 14 years.

关于Cosentyx®（secukinumab），Cosentyx是一种完全人类生物制剂，可特异性靶向和阻断白细胞介素-17A（IL-17A），这是一种参与银屑病关节炎（PsA），中度至重度斑块状银屑病炎症的重要细胞因子，强直性脊柱炎（AS）和非放射性轴性脊柱关节炎（nr-axSpA）.7,8 Cosentyx是一种经过验证的药物，临床研究已超过14年。

The medicine is backed by robust evidence, including 8 years of real-world data in adults and 5 years of long-term safety and efficacy in adults with moderate to severe plaque psoriasis, PsA and AS.1,9-15 These data strengthen the position of Cosentyx as a treatment across AS, nr-axSpA, PsA, moderate to severe plaque psoriasis (adult and pediatric) and two subtypes of juvenile idiopathic arthritis (JIA), enthesitis-related arthritis and juvenile psoriatic arthritis.1 More than 1 million patients have been treated with Cosentyx worldwide since its launch in 2015.16 Cosentyx is approved in more than 100 countries, most recently gaining approval for JIA and hidradenitis suppurativa in Europe.17-20  .

该药物得到了有力证据的支持，包括成人8年的实际数据以及中重度斑块状银屑病，PsA和AS患者5年的长期安全性和有效性.1,9-15这些数据加强了Cosentyx作为AS，nr-axSpA，PsA，中度至重度斑块状银屑病（成人和儿科）以及青少年特发性关节炎（JIA），附着点炎相关性关节炎和青少年银屑病关节炎的两种亚型.1自2015年推出以来，全球已有100多万患者接受Cosentyx治疗.16 Cosentyx在100多个国家获得批准，最近在欧洲获得JIA和化脓性汗腺炎的批准.17-20。

INDICATIONSCOSENTYX® (secukinumab) is a prescription medicine used to treat:

适应症ScosentyX®（苏金单抗）是一种用于治疗的处方药：

people 6 years of age and older with moderate to severe plaque psoriasis (PsO) that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light alone or with systemic therapy)

6岁及以上患有中度至重度斑块状银屑病（PsO）的人，其涉及身体的大面积或多个区域，并且可能受益于注射或丸剂（全身治疗）或光疗（使用紫外线或紫外线治疗单独或与全身治疗）

people 2 years of age and older with active psoriatic arthritis (PsA)

2岁及以上患有活动性银屑病关节炎（PsA）的人

adults with active ankylosing spondylitis (AS)

成人活动性强直性嵴柱炎

adults with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation

成人活动性非放射性轴性脊柱关节炎（nr-axSpA）和客观炎症迹象

people 4 years of age and older with active enthesitis-related arthritis (ERA)

4岁及以上患有活动性附着点炎相关性关节炎（ERA）的人

IMPORTANT SAFETY INFORMATIONDo not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the Medication Guide for a complete list of ingredients.

重要的安全信息如果您对苏金单抗或COSENTYX中的任何其他成分有严重的过敏反应，请勿使用COSENTYX。有关成分的完整列表，请参阅“用药指南”。

What is the most important information I should know about COSENTYX?COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as:

什么是我应该知道的关于COSENTYX的最重要的信息？COSENTYX是一种影响你的免疫系统的药物。COSENTYX可能会增加严重副作用的风险，例如：

InfectionsCOSENTYX may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have died from these infections.

InfectionsCOSENTYX可能会降低免疫系统抵抗感染的能力，并可能增加感染的风险。有些人死于这些感染。

Your doctor should check you for tuberculosis (TB) before starting treatment with COSENTYX.

在开始使用COSENTYX治疗之前，您的医生应该检查您的结核病（TB）。

If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with COSENTYX and during treatment with COSENTYX.

如果您的医生认为您有患结核病的风险，您可以在开始使用COSENTYX治疗之前和使用COSENTYX治疗期间接受结核病药物治疗。

Your doctor should watch you closely watch for signs and symptoms of TB during treatment with COSENTYX. Do not take COSENTYX if you have an active TB infection.

在使用COSENTYX治疗期间，您的医生应该密切关注结核病的体征和症状。如果您有活动性结核感染，请勿服用COSENTYX。

Before starting COSENTYX, tell your doctor if you:

在开始COSENTYX之前，告诉你的医生，如果你：

are being treated for an infection

正在接受感染治疗

have an infection that does not go away or that keeps coming back

有一种不会消失或不断回来的感染

have TB or have been in close contact with someone with TB

患有结核病或与结核病患者密切接触

think you have an infection or have symptoms of an infection such as: fevers, sweats, or chills; muscle aches; cough; shortness of breath; blood in your phlegm; weight loss; warm, red, or painful skin or sores on your body; diarrhea or stomach pain; burning when you urinate or urinate more often than normal.

认为您有感染或有感染症状，如：发烧，出汗或发冷；肌肉酸痛；咳嗽；气短；痰中血；减肥；身体上温暖，红色或疼痛的皮肤或溃疡；腹泻或胃痛；排尿或排尿的频率比正常情况下高。

After starting COSENTYX, call your doctor right away if you have any signs of infection listed above. Do not use COSENTYX if you have any signs of infection unless you are instructed to by your doctor.

开始COSENTYX后，如果您有上述任何感染迹象，请立即致电您的医生。如果您有任何感染迹象，请勿使用COSENTYX，除非您的医生指示您。

What are the possible side effects of COSENTYX?COSENTYX may cause serious side effects, including:

COSENTYX可能有哪些副作用？COSENTYX可能会导致严重的副作用，包括：

Inflammatory bowel diseaseNew cases of inflammatory bowel disease or 'flare-ups' can happen with COSENTYX and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn's disease), tell your doctor if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea..

炎症性肠病COSENTYX可发生炎症性肠病或“眩晕”的新病例，有时可能很严重。如果您患有炎症性肠病（溃疡性结肠炎或克罗恩病），请告诉您的医生您在使用COSENTYX治疗期间是否有恶化的疾病症状或出现胃痛或腹泻的新症状。。

Serious allergic reactionsSerious allergic reactions can occur. Get emergency medical help right away if you get any of the following symptoms: feeling faint; swelling of your face, eyelids, lips, mouth, tongue, or throat; trouble breathing or throat tightness; chest tightness; skin rash or hives (red, itchy bumps).If you have a severe allergic reaction, do not give another injection of COSENTYX..

严重的过敏反应可能发生严重的过敏反应。如果您出现以下任何症状，请立即获得紧急医疗帮助：感觉晕眩；脸部，眼睑，嘴唇，嘴巴，舌头或喉咙肿胀；呼吸困难或喉咙紧绷；胸闷；皮疹或荨麻疹（红色，瘙痒颠簸）。如果您有严重的过敏反应，请勿再注射COSENTYX。。

Severe skin reactions that look like eczema can happen during treatment with COSENTYX from days to months after your first dose and can sometimes lead to hospitalization. Your healthcare provider may temporarily stop treatment with COSENTYX if you develop severe skin reactions. Tell your healthcare provider if you have any of the following signs or symptoms: redness or rash, itching, small bumps or patches, your skin is dry or feels like leather, blisters on the hands or feet that ooze or become crusty and skin peeling..

在第一次给药后数天至数月内，使用COSENTYX治疗期间可能会出现类似湿疹的严重皮肤反应，有时会导致住院治疗。如果您出现严重的皮肤反应，您的医疗保健提供者可能会暂时停止使用COSENTYX治疗。如果您有以下任何体征或症状，请告诉您的医疗保健提供者：发红或皮疹，瘙痒，小肿块或斑块，您的皮肤干燥或感觉像皮革，手脚上的水泡渗出或变硬，皮肤剥落。。

The most common side effects of COSENTYX include: cold symptoms, diarrhea, and upper respiratory infections.

COSENTYX最常见的副作用包括：感冒症状，腹泻和上呼吸道感染。

These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects.

这些并不是COSENTYX所有可能的副作用。打电话给你的医生，征求有关副作用的医疗建议。

Before using COSENTYX, tell your doctor if you:

使用COSENTYX之前，请告诉您的医生您是否：

have any of the conditions or symptoms listed above for infections.

有上述任何感染的病症或症状。

have inflammatory bowel disease (Crohn's disease or ulcerative colitis).

患有炎症性肠病（克罗恩病或溃疡性结肠炎）。

are allergic to latex. The needle cap on the COSENTYX Sensoready® pen, and 150 mg/mL and 75 mg/0.5 mL prefilled syringes contains latex.

对乳胶过敏。COSENTYX Sensoready®笔上的针帽以及150 mg/mL和75 mg/0.5 mL预充式注射器均含有乳胶。

have recently received or are scheduled to receive an immunization (vaccine). People who take COSENTYX should not receive live vaccines. Children should be brought up to date with all vaccines before starting COSENTYX.

最近已收到或计划接受免疫接种（疫苗）。服用COSENTYX的人不应该接种活疫苗。在开始COSENTYX之前，应该让儿童接种所有疫苗。

have any other medical conditions and all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

有任何其他医疗条件和你服用的所有药物，包括处方药和非处方药，维生素和草药补充剂。

are pregnant or plan to become pregnant. It is not known if COSENTYX can harm your unborn baby. You and your doctor should decide if you will use COSENTYX.

怀孕或计划怀孕。目前尚不清楚COSENTYX是否会伤害你未出生的婴儿。你和你的医生应该决定你是否会使用COSENTYX。

are breastfeeding or plan to breastfeed. It is not known if COSENTYX passes into your breast milk.

是母乳喂养或计划母乳喂养。目前尚不清楚COSENTYX是否会进入你的母乳。

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

鼓励您向FDA报告处方药的不良副作用。访问www.fda.gov/medwatch或致电1-800-fda-1088。

Please click here for Cosentyx full Prescribing Information.

请点击此处获取Cosentyx完整的处方信息。

DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as 'potential,' 'can,' 'will,' 'plan,' 'may,' 'could,' 'would,' 'expect,' 'anticipate,' 'look forward,' 'believe,' 'committed,' 'investigational,' 'pipeline,' 'launch,' or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products.

免责声明本新闻稿包含1995年“美国私人证券诉讼改革法”含义内的前瞻性声明。前瞻性陈述通常可以用“潜力”，“可以”，“将会”，“计划”，“可能”，“可以”，“期望”，“预期”，“期待”，“期待”，“相信”，“承诺”，“研究”，“管道”，“启动”或类似条款，或通过关于潜在营销批准的明示或暗示的讨论，本新闻稿中描述的研究或批准产品的新适应症或标签，或有关此类产品未来潜在收入的标签。

You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements.

你不应该过分依赖这些陈述。这种前瞻性陈述是基于我们目前对未来事件的信念和期望，并且存在重大的已知和未知风险和不确定性。如果实现这些风险或不确定性中的一个或多个，或者如果基础假设证明不正确，则实际结果可能与前瞻性声明中提出的结果大不相同。

There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future.

不能保证本新闻稿中描述的研究或批准产品将被提交或批准销售，或在任何市场或任何特定时间用于任何其他适应症或标签。也不能保证此类产品将来在商业上取得成功。

In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government,.

特别是，我们对这些产品的期望可能会受到研究和开发中固有的不确定性的影响，包括临床试验结果和对现有临床数据的额外分析；监管行动或延误或政府监管一般；全球卫生保健成本控制趋势，包括政府，。

About NovartisNovartis is a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide..

关于诺华诺华是一家专注的创新药物公司。我们每天都在努力重新设计药物来改善和延长人们的生活，以便患者，医疗保健专业人员和社会在面对严重疾病时获得权力。我们的药物覆盖全球超过2.5亿人。。

Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

与我们一起的Reimagine medicine：访问我们https://www.novartis.com并通过LinkedIn，Facebook，X/Twitter和Instagram与我们联系。

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Data on file. CAIN457F2310 (MEASURE 1 and 2): Pooled Safety Data. Novartis Pharmaceuticals Corp; July 23, 2018.

数据在文件中。CAIN457F2310（措施1和2）：汇总安全数据。诺华制药公司；2018年7月23日。

Data on file. CAIN457F2310 and CAIN457F2305 summary of 5-year clinical safety in (ankylosing spondylitis). Novartis Pharmaceuticals Corp; May 2019.

数据在文件中。CAIN457F2310和CAIN457F2305（强直性脊柱炎）5年临床安全性总结。诺华制药公司；2019年5月。

Data on file. CAIN457F2312 Data Analysis Report. Novartis Pharmaceuticals Corp; November 2008.

数据在文件中。CAIN457F2312数据分析报告。诺华制药公司；2008年11月。

McInnes IB, Mease PJ, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2015;386:1137-46.

McInnes IB，Mease PJ，Kirkham B等人Secukinumab，一种人类抗白细胞介素-17A单克隆抗体，用于银屑病关节炎患者（FUTURE 2）：一项随机，双盲，安慰剂对照的3期临床试验。柳叶刀2015；386:1137-46.

Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; January 2023.

数据在文件中。COSENTYX访问。诺华制药公司；2023年1月。

Gottlieb AB, Deodhar A, Mcinnes IB, et al. Long-term Safety of Secukinumab Over Five Years in Patients with Moderate-to-severe Plaque Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Update on Integrated Pooled Clinical Trial and Post-marketing Surveillance Data. Acta Derm Venereol. 2022;102:adv00698..

Gottlieb AB，Deodhar A，Mcinnes IB等。中重度斑块型银屑病，银屑病关节炎和强直性脊柱炎患者5年以上苏金单抗的长期安全性：综合汇总临床试验和上市后监测数据的最新情况。Acta Derm Venereol。2022;102:adv00698。。

Novartis AG. 2021. Novartis Cosentyx® receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-treatment-children-and-adolescents-enthesitis-related-arthritis-and-psoriatic-arthritis [Last accessed: February 2023]..

诺华公司2021。诺华Cosentyx®获得FDA批准，用于治疗患有附着点炎相关性关节炎和银屑病关节炎的儿童和青少年。[新闻稿]。可在：https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-treatment-children-and-adolescents-enthesitis-related-arthritis-and-psoriatic-arthritis[最后访问时间：2023年2月]。。

Novartis AG. 2022. Novartis Cosentyx® (secukinumab) receives positive CHMP opinion for expanded use in childhood arthritic conditions. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-secukinumab-receives-positive-chmp-opinion-expanded-use-childhood-arthritic-conditions [Last accessed: February 2023]..

诺华公司2022。诺华Cosentyx®（苏金单抗）获得积极的CHMP意见，扩大用于儿童关节炎病症。[新闻稿]。可在：https://www.novartis.com/news/media-releases/novartis-cosentyx-secukinumab-receives-positive-chmp-opinion-expanded-use-childhood-arthritic-conditions[最后访问时间：2023年2月]。。

Novartis Europharm Limited. Cosentyx® (secukinumab): Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf [Last accessed: September 2023].

诺华Europharm有限公司。Cosentyx®（苏金单抗）：产品特性总结。可在：https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf[最后访问时间：2023年9月]。

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