AstraZeneca’s Fasenra (benralizumab) has been recommended for approval in the European Union (EU) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal.1,2.

阿斯利康的Fasenra（贝那利珠单抗）已被推荐在欧盟（EU）批准作为成人复发性或难治性嗜酸性肉芽肿伴多血管炎（EGPA）患者的附加治疗。EGPA是一种罕见的免疫介导的血管炎，可导致多器官损伤，未经治疗可能致命。

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the MANDARA Phase III trial published in The New England Journal of Medicine,3 which compared the efficacy and safety of Fasenra to the only approved EGPA treatment, mepolizumab, in patients with relapsing or refractory EGPA.3-5 MANDARA was the first head-to-head non-inferiority trial of biologics in patients with EGPA.4,6 Patients were randomised to receive either a single 30 mg subcutaneous injection of Fasenra, or three separate 100 mg subcutaneous injections of mepolizumab every four weeks.3,4  .

欧洲药品管理局（European Medicines Agency）的人类使用药品委员会（CHMP）对《新英格兰医学杂志》3上发表的MANDARA III期临床试验的结果发表了积极的意见，该试验比较了Fasenra与复发或难治性EGPA患者唯一批准的EGPA治疗mepolizumab的疗效和安全性[3-5]。MANDARA是EGPA患者生物制剂的第一个头对头非劣效性试验[4,6]。患者被随机分配接受单次30 mg皮下注射Fasenra，或每四周三次单独100 mg皮下注射mepolizumab[3,4]。

In the trial, nearly 60% of Fasenra-treated patients achieved remission which was comparable to mepolizumab-treated patients.3 Data also showed 41% of Fasenra-treated patients fully tapered off oral corticosteroids (OCS) (vs. 26% in the comparator arm (difference: 16%; 95% CI: 1,31)).3

在该试验中，近60%的Fasenra治疗患者达到缓解，与mepolizumab治疗的患者相当[3]。数据还显示，41%的Fasenra治疗患者完全减少口服皮质类固醇（OCS）（对比组为26%）（差异：16%；95%可信区间：1,31））。3

Bernhard Hellmich, Chair of the Department of Internal Medicine, Rheumatology, and Immunology at the Medius Klinik Kirchheim, Teaching Hospital of the University of Tübingen, Co-Director of the Vasculitis Center Tübingen-Kirchhei, and MANDARA Principal Investigator said: “People living with EGPA in Europe often face debilitating symptoms and suffer serious and long-lasting side effects from treatment with long-term oral corticosteroids.

蒂宾根大学教学医院Medius Klinik Kirchheim内科，风湿病和免疫学系主任，蒂宾根Kirchhei血管炎中心联合主任和MANDARA首席研究员Bernhard Hellmich说：“欧洲EGPA患者经常面临衰弱症状，长期口服皮质类固醇治疗会产生严重而持久的副作用。

With its unique mechanism of action that leads to near complete depletion of eosinophils, Fasenra represents a much-needed potential treatment option for EGPA patients to help them achieve remission and taper off steroid therapy.”  .

Fasenra具有独特的作用机制，可导致嗜酸性粒细胞近乎完全耗尽，是EGPA患者急需的潜在治疗选择，可帮助他们缓解并逐渐减少类固醇治疗。”

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca said: “With today’s recommendation, the EGPA community in Europe is one step closer to accessing a new and convenient treatment option to alleviate some of the impact of this debilitating disease. With over 15 years of clinical data, Fasenra is a well-established, leading treatment for severe eosinophilic asthma, and now has the potential to transform care for patients with EGPA.

阿斯利康生物制药业务部执行副总裁 Ruud Dobber 说： “随着今天的推荐，欧洲的 EGPA 群体离获得一种新的、方便的治疗选择又近了一步，这种治疗选择可以减轻这种使人衰弱的疾病的一些影响。Fasenra拥有超过15年的临床数据，是治疗严重嗜酸性粒细胞性哮喘的成熟、领先的疗法，现在有可能改变对EGPA患者的治疗。

Today’s news demonstrates the potential of Fasenra to help patients suffering from eosinophilic diseases beyond severe asthma.”.

今天的新闻证明了Fasenra在帮助患有严重哮喘以外的嗜酸性粒细胞疾病的患者方面的潜力。”。

The safety and tolerability profile for Fasenra in the MANDARA trial was consistent with the known profile of the medicine.3

MANDARA试验中Fasenra的安全性和耐受性概况与已知的药物概况一致。3

Approximately half of patients with EGPA have adult-onset severe eosinophilic asthma (SEA) and often have sinus and nasal symptoms.2,7,8 If approved, Fasenra would be only the second biologic approved to treat this disease.3,4

大约一半的EGPA患者患有成人发作的严重嗜酸性粒细胞性哮喘（SEA），并且经常有鼻窦和鼻腔症状。2,7,8如果获得批准，Fasenra将是第二个被批准用于治疗这种疾病的生物制剂。3,4

Fasenra was recently approved in the US for the treatment of EGPA9 and is also approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA) in more than 80 countries including the US, Japan, EU and China.10-13 It is also approved in children and adolescents ages six and above in the US and Japan.12.

Fasenra最近在美国被批准用于治疗EGPA9，并且在包括美国，日本，欧盟和中国在内的80多个国家被批准作为严重嗜酸性粒细胞性哮喘（SEA）的附加维持治疗.10-13它也被批准用于美国和日本6岁及以上的儿童和青少年。

MANDARA

MANDARA

MANDARA was a Phase III, randomised, double-blinded, active-controlled trial, which compared the efficacy and safety of Fasenra to mepolizumab in adult patients with relapsing or refractory EGPA.4 In the trial, 140 patients were randomised 1:1 to receive either a single 30 mg subcutaneous injection of Fasenra or three separate 100 mg subcutaneous injections of the active comparator every four weeks.3.

MANDARA是一项III期，随机，双盲，主动对照试验，比较了Fasenra与mepolizumab在复发或难治性EGPA成年患者中的疗效和安全性。在该试验中，140名患者以1:1的比例随机接受单次30 mg皮下注射Fasenra或每四周三次单独100 mg皮下注射活性比较物。

The primary endpoint was the proportion of patients who were in remission at both weeks 36 and 48.4 Remission is defined as Birmingham Vasculitis Activity Score (BVAS)=0 and OCS dose less than or equal to 4 mg/day.4 A secondary endpoint was the proportion of patients who were able to fully taper off OCS at weeks 48 through 52.3 The primary statistical analysis was to demonstrate non-inferiority of Fasenra versus mepolizumab based on the primary endpoint.3.

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4 mg/天。次要终点是在第48周至第52周能够完全减少OCS的患者比例。主要统计分析是根据主要终点证明法新拉与美泊利珠单抗的非劣效性。

Fasenra

Fasenra

Fasenra (benralizumab) is currently approved in more than 80 countries, including the US, EU, Japan, and China.10-13 Fasenra has been prescribed to over 130,000 patients globally.18

Fasenra（benralizumab）目前已在包括美国，欧盟，日本和中国在内的80多个国家获得批准.10-13 Fasenra已被全球超过130000名患者处方.18

Fasenra is in development for other diseases including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.19-21

Fasenra正在开发其他疾病，包括慢性阻塞性肺病，慢性鼻-鼻窦炎伴鼻息肉和嗜酸性粒细胞增多综合征.19-21

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

Fasenra 由阿斯利康开发，并从日本 Kyowa Kirin Co., Ltd. 的全资子公司 BioWa, Inc. 获得内许可。

AstraZeneca in Respiratory & Immunology

阿斯利康呼吸与免疫学

Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company.

呼吸与免疫学是阿斯利康生物制药的一部分，是该公司的关键疾病领域和增长驱动力。

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets.

阿斯利康是呼吸系统护理领域的公认领导者，拥有50年的历史，并且在免疫介导疾病方面的药物组合不断增加。该公司致力于通过吸入药物、生物制剂和针对以前无法达到的生物目标的新模式的管道和组合，解决这些慢性病（通常使人衰弱）的巨大未满足需求。

Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases..

我们的目标是提供改变生命的药物，帮助消除COPD作为主要死亡原因，消除哮喘发作，并实现免疫介导疾病的临床缓解。。

AstraZeneca

阿斯利康

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.

阿斯利康（LSE/STO/Nasdaq:AZN）是一家全球科学领先的生物制药公司，专注于肿瘤学，罕见病和生物制药（包括心血管，肾脏和代谢以及呼吸和免疫学）处方药的发现，开发和商业化。

Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca.

阿斯利康的创新药物总部位于英国剑桥，在125多个国家销售，全球数百万患者使用。请访问astrazeneca.com并在社交媒体@astrazeneca上关注该公司。