WILMINGTON, Del.--(BUSINESS WIRE)--Positive high-level results from the MANDARA Phase III trial showed AstraZeneca’s FASENRA (benralizumab) met the primary endpoint of the trial and demonstrated non-inferior rates of remission compared to mepolizumab in patients with eosinophilic granulomatosis with polyangiitis (EGPA) who were receiving oral corticosteroids (OCS) with or without stable immunosuppressive therapy..

威尔明顿，Del.-（商业线）-MANDARA III期临床试验的阳性高水平结果显示，AstraZeneca的FASENRA（贝那利珠单抗）达到了试验的主要终点，与mepolizumab相比，嗜酸性粒细胞肉芽肿伴多血管炎患者的缓解率不逊色EGPA）谁接受口服皮质类固醇（OCS）有或没有稳定的免疫抑制剂治疗。。

MANDARA is the first Phase III head-to-head trial of biologics in EGPA and compared the efficacy and safety of FASENRA versus mepolizumab, the only currently approved treatment.1,2 In the blinded trial, patients were randomized to receive either a single 30mg subcutaneous injection of FASENRA or three separate 100mg subcutaneous injections of mepolizumab once every four weeks.1,2.

MANDARA是EGPA生物制剂的第一个III期头对头试验，比较了FASENRA与目前唯一批准的治疗方法mepolizumab的疗效和安全性[1,2]。在盲法试验中，患者随机接受单次30mg皮下注射FASENRA或三次单独100mg皮下注射mepolizumab，每四周一次。

EGPA is a rare, immune-mediated vasculitis that is caused by inflammation of small to medium-sized blood vessels.3,4 Approximately half of patients with EGPA have concomitant adult-onset severe eosinophilic asthma (SEA).5 EGPA can result in damage to multiple organs, including lungs, skin, heart, gastrointestinal tract and nerves, which accumulates over time and without treatment can be fatal.3,6.

EGPA是一种罕见的免疫介导性血管炎，由中小型血管炎症引起[3,4]。大约一半的EGPA患者伴有成人发病的严重嗜酸性粒细胞性哮喘（SEA）[5]。EGPA可导致损伤多个器官，包括肺，皮肤，心脏，胃肠道和神经，随着时间的推移积累而不治疗可能是致命的。

Dr Michael Wechsler, Principal Investigator said: “The positive MANDARA trial results are exciting because patients with eosinophilic granulomatosis with polyangiitis today have limited treatment options but face crippling symptoms, which can even be fatal if not treated. This trial demonstrates that a biologic medicine given in a single monthly injection could help patients achieve remission rates comparable to the current standard of care, adding to the importance of benralizumab as a potential treatment option for eosinophilic granulomatosis with polyangiitis.”.

Michael Wechsler博士，首席研究员说：“MANDARA阳性试验结果令人兴奋，因为今天患有多血管炎的嗜酸性粒细胞肉芽肿病患者的治疗选择有限，但面临严重症状，如果不治疗甚至可能致命。该试验表明，每月一次注射生物制剂可以帮助患者达到与目前的护理标准相当的缓解率由于贝那利珠单抗作为嗜酸性粒细胞肉芽肿伴多血管炎的潜在治疗选择的重要性。

Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “The positive results from MANDARA demonstrate that FASENRA, which has a unique mechanism of action and directly targets eosinophils, can help patients achieve remission from the debilitating impacts of this inflammatory disease with a more convenient single monthly subcutaneous injection.”.

阿斯利康生物制药研发执行副总裁Sharon Barr说：“MANDARA的积极成果表明，FASENRA具有独特的作用机制并直接靶向嗜酸性粒细胞，可以帮助患者从这种炎症的衰弱影响中获得缓解疾病更方便的单月皮下注射“。

The safety and tolerability profile for FASENRA in the trial was consistent with the known profile of the medicine.

FASENRA在试验中的安全性和耐受性概况与已知的药物概况一致。

Full results from MANDARA will be presented at an upcoming medical meeting and data will be shared with health authorities around the world.

曼达拉的全部成果将在即将召开的医学会议上公布，数据将与世界各地的卫生当局分享。

FASENRA is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of blood and tissue eosinophils in most patients via apoptosis (programmed cell death).7,8

FASENRA是一种单克隆抗体，可直接与嗜酸性粒细胞上的IL-5受体α结合，并吸引自然杀伤细胞，通过细胞凋亡（程序性细胞死亡）诱导大多数患者血液和组织嗜酸性粒细胞迅速完全消耗.7,8

FASENRA is currently approved as an add-on maintenance treatment for SEA in the US, EU, Japan and other countries, and is approved for self-administration in the US, EU and other countries.9,10 The FDA granted Orphan Drug Designation for FASENRA for EGPA in 2018 and AstraZeneca continues to explore FASENRA’s potential beyond severe asthma, as a treatment across many diseases where eosinophils are expected to play a role.11-14.

FASENRA目前在美国，欧盟，日本和其他国家被批准作为SEA的附加维护治疗，并被批准在美国，欧盟和其他国家进行自我管理.9,10 FDA授予孤儿药名称2018年用于EGPA的FASENRA和阿斯利康继续探索FASENRA超越严重哮喘的潜力，作为嗜酸性粒细胞有望发挥作用的许多疾病的治疗方法。

IMPORTANT SAFETY INFORMATION

重要的安全信息

CONTRAINDICATIONS

禁忌症

Known hypersensitivity to benralizumab or excipients.

已知对贝那利珠单抗或赋形剂的超敏反应。

WARNINGS AND PRECAUTIONS

警告和注意事项

Hypersensitivity Reactions

超敏反应

Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days). Discontinue in the event of a hypersensitivity reaction.

给予FASENRA后发生过敏反应（如过敏反应，血管性水肿，荨麻疹，皮疹）。这些反应通常在给药后数小时内发生，但在某些情况下具有延迟发作（即数天）。在超敏反应的情况下停止。

Acute Asthma Symptoms or Deteriorating Disease

急性哮喘症状或恶化的疾病

FASENRA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.

FASENRA不应用于治疗急性哮喘症状，急性加重或急性支气管痉挛。

Reduction of Corticosteroid Dosage

减少皮质类固醇剂量

Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy..

开始用FASENRA治疗后，不要突然停止全身或吸入皮质类固醇。如果合适的话，皮质类固醇剂量的减少应该是渐进的，并且在医生的直接监督下进行。皮质类固醇剂量的减少可能与全身戒断症状和/或先前由全身皮质类固醇治疗抑制的揭露条件有关。。

Parasitic (Helminth) Infection

寄生虫（蠕虫）感染

It is unknown if FASENRA will influence a patient’s response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with FASENRA. If patients become infected while receiving FASENRA and do not respond to anti-helminth treatment, discontinue FASENRA until infection resolves..

FASENRA是否会影响患者对蠕虫感染的反应尚不清楚。在开始用FASENRA治疗之前治疗预先存在蠕虫感染的患者。如果患者在接受FASENRA时感染并且对抗蠕虫治疗没有反应，请停止FASENRA直至感染消退。。

ADVERSE REACTIONS

不良反应

The most common adverse reactions (incidence ≥ 5%) include headache and pharyngitis. Injection site reactions (eg, pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with FASENRA compared with 1.9% in patients treated with placebo.

最常见的不良反应（发生率≥5%）包括头痛和咽炎。注射部位反应（如疼痛，红斑，瘙痒，丘疹）发生率为2.2%，而安慰剂组为1.9%。

USE IN SPECIFIC POPULATIONS

在特定人群中使用

A pregnancy exposure registry monitors pregnancy outcomes in women exposed to FASENRA during pregnancy. To enroll call 1-877-311-8972 or visit www.mothertobaby.org/fasenra.

怀孕暴露登记处监测怀孕期间接触FASENRA的妇女的妊娠结局。要注册电话1-877-311-8972或访问www.mothertobaby.org/fasenra。

The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy..

来自临床试验的妊娠暴露数据不足以告知药物相关风险。单克隆抗体如贝那利珠单抗在妊娠晚期通过胎盘运输；因此，妊娠晚期对胎儿的潜在影响可能更大。。

INDICATION

指示

FASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

FASENRA适用于12岁及以上重度哮喘患者的附加维持治疗，并具有嗜酸性粒细胞表型。

FASENRA is not indicated for treatment of other eosinophilic conditions

FASENRA不适用于治疗其他嗜酸性粒细胞疾病

FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus

FASENRA不适用于缓解急性支气管痉挛或哮喘状态

Please read full Prescribing Information, including Patient Information and Instructions for Use.

请阅读完整的处方信息，包括患者信息和使用说明。

You may report side effects related to AstraZeneca products.

您可能会报告与阿斯利康产品相关的副作用。

Notes

笔记

EGPA

EGPA

EGPA, formerly known as Churg-Strauss Syndrome, is a rare, immune-mediated inflammatory disease that is caused by inflammation of small to medium-sized blood vessels.3,4 It is estimated that 118,000 people throughout the world live with EGPA.15

EGPA，以前称为Churg-Strauss综合征，是一种罕见的免疫介导的炎症性疾病，由中小型血管炎症引起[3,4]。据估计，全世界有118000人生活在EGPA.15

EGPA can result in damage to multiple organs, including lungs, skin, heart, gastrointestinal tract and nerves.3 The most common symptoms and signs include extreme fatigue, weight loss, muscle and joint pain, rashes, nerve pain, sinus and nasal symptoms, and shortness of breath.3,6 Without treatment, the disease may be fatal.3,6.

EGPA可导致多器官损伤，包括肺，皮肤，心脏，胃肠道和神经.3最常见的症状和体征包括极度疲劳，体重减轻，肌肉和关节疼痛，皮疹，神经疼痛，鼻窦和鼻部症状，和呼吸短促.3,6如果不治疗，这种疾病可能是致命的.3,6。

Elevated levels of eosinophils play a central role in EGPA disease pathophysiology.4 All patients with EGPA have very high levels of eosinophils at some point in their disease, both in peripheral blood and in affected tissues or organs.3,6 Approximately half of patients with EGPA have concomitant adult-onset SEA, and often have sinus and nasal symptoms.3,5.

嗜酸性粒细胞水平升高在EGPA疾病病理生理学中起着核心作用[4]。所有EGPA患者在其疾病的某个阶段，无论是外周血还是受影响的组织或器官，嗜酸性粒细胞水平都很高[3,6]。大约一半的EGPA伴有成人发病的SEA，常伴有鼻窦和鼻腔症状[3,5]。

There are limited treatment options for EGPA. Patients are often treated with chronic high-dose OCS and can experience recurrent relapses when attempting to taper off OCS.6,16 Mepolizumab is currently the only approved treatment for EGPA.2

EGPA的治疗选择有限。患者通常接受慢性高剂量OCS治疗，试图减少OCS时可能会复发[6,16]。Mepolizumab是目前唯一批准的EGPA治疗方法

MANDARA

曼达拉

MANDARA was a randomized, double blind, double-dummy, active-controlled, parallel group, multicentre 52-week Phase III trial which compared the efficacy and safety of FASENRA to mepolizumab in adult patients with relapsing or refractory EGPA.1 In the blinded trial, 140 patients were randomized 1:1 (70 per treatment group) to receive either a single 30mg subcutaneous injection of FASENRA or three separate 100mg subcutaneous injections of mepolizumab once every four weeks.1.

MANDARA是一项随机，双盲，双模拟，主动对照，平行组，多中心52周III期临床试验，比较了FASENRA与mepolizumab治疗复发或难治性EGPA成人患者的疗效和安全性.1在盲法试验中，140名患者随机1:1（每个治疗组70名）接受单次30mg皮下注射FASENRA或三次单独100mg皮下注射mepolizumab，每四周一次。

The primary endpoint was the proportion of patients who were in remission at both weeks 36 and 48.1 Remission is defined as Birmingham Vasculitis Activity Score (BVAS)=0 and OCS dose less than or equal to 4mg/day.1 FASENRA remission was compared to the historical placebo rate from mepolizumab’s Phase III trial, MIRRA.17 The primary statistical analysis was to demonstrate non-inferiority of FASENRA versus mepolizumab based on the primary endpoint..

主要终点是在第36周和第48周缓解的患者比例。缓解定义为伯明翰血管炎活动评分（BVAS）=0，OCS剂量小于或等于4mg/天.1将FASENRA缓解与来自mepolizumab III期试验的历史安慰剂率，MIRRA.17主要统计分析是基于主要终点证明FASENRA与mepolizumab的非劣效性。。

All patients who complete the 52-week double-blind treatment period may be eligible to continue into an open label extension (OLE) period, intended to allow each patient at least one year of treatment with open-label FASENRA.1

所有完成52周双盲治疗期的患者可能有资格继续进入开放标签延长（OLE）期，旨在允许每位患者至少一年使用开放标签FASENRA治疗

Mepolizumab is a humanized IL-5 antagonist monoclonal antibody.2

Mepolizumab是一种人源化IL-5拮抗剂单克隆抗体

FASENRA

发票

FASENRA (benralizumab) is currently approved as an add-on maintenance treatment for SEA in the US, EU, Japan and other countries, and is approved for self-administration in the US, EU and other countries.9,10 FASENRA has been studied in almost 4,000 patients in global clinical trials.18-22

FASENRA（贝那利珠单抗）目前被批准作为美国，欧盟，日本和其他国家SEA的附加维持治疗，并被批准在美国，欧盟和其他国家进行自我管理.9,10 FASENRA已被研究在全球临床试验的近4000名患者中

FASENRA is in development for other eosinophilic diseases including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.12-14

FASENRA正在开发其他嗜酸性粒细胞疾病，包括慢性阻塞性肺病，伴有鼻息肉的慢性鼻-鼻窦炎和嗜酸性粒细胞增多综合征.12-14

FASENRA was developed by AstraZeneca and is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Kirin Co., Ltd., Japan.

FASENRA由AstraZeneca开发，并获得日本Kyowa Kirin Co.，Ltd。的合资子公司BioWa，Inc.的许可。

AstraZeneca in Respiratory and Immunology

阿斯利康呼吸与免疫学

Respiratory & Immunology, part of BioPharmaceuticals, is one of AstraZeneca’s main disease areas and is a key growth driver for the Company.

呼吸与免疫学是生物制药的一部分，是阿斯利康的主要疾病领域之一，也是该公司的关键增长动力。

AstraZeneca is an established leader in respiratory care with a 50-year heritage. The Company aims to transform the treatment of asthma and COPD by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death. The Company’s early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction..

阿斯利康（AstraZeneca）是呼吸系统护理领域的领导者，具有50年的传统。该公司旨在通过关注早期的生物学主导治疗，消除可预防的哮喘发作，并将COPD作为三大主要死亡原因，改变哮喘和COPD的治疗方法。该公司的早期呼吸研究集中在涉及免疫机制，肺损伤和疾病和神经元功能障碍中异常细胞修复过程的新兴科学。。

With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas. The Company’s growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential, in areas including rheumatology (including systemic lupus erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases.

通过呼吸和免疫学的共同途径和潜在的疾病驱动因素，阿斯利康正在遵循从慢性肺病到免疫学驱动的疾病领域的科学。该公司在免疫学领域的应用越来越广泛，主要集中在风湿病学（包括系统性红斑狼疮），皮肤病学，胃肠病学和系统性嗜酸性粒细胞驱动疾病等五个具有多种疾病潜力的中后期特许经营。

AstraZeneca’s ambition in Respiratory & Immunology is to achieve disease modification and durable remission for millions of patients worldwide..

阿斯利康在呼吸与免疫学方面的雄心壮志是为全球数百万患者实现疾病改善和持久缓解。。

AstraZeneca

阿斯利康

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide.

阿斯利康是一家以科学为主导的全球性生物制药公司，专注于肿瘤和生物制药处方药的发现，开发和商业化，包括心血管，肾脏和新陈代谢以及呼吸和免疫学。阿斯利康总部设在英国剑桥，在100多个国家开展业务，其创新药物被全球数百万患者所使用。

For more information, please visit www.astrazeneca-us.com and follow the Company on social media @AstraZeneca..

欲了解更多信息，请访问www.astrazeneca-us.com并在社交媒体@astrazeneca上关注该公司。。

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工具书类

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