Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for EMBLAVEO

辉瑞公司（纽约证券交易所：PFE）今天宣布，欧盟委员会（EC）已授予EMBLAVEO上市许可

(aztreonam-avibactam) for the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis. It is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options..

（氨曲南-阿维巴坦）用于治疗患有复杂腹腔内感染（cIAI），医院获得性肺炎（HAP）（包括呼吸机相关性肺炎（VAP））和复杂尿路感染（cUTI）（包括肾盂肾炎）的成年患者。它也适用于治疗有限治疗选择的成年患者中有氧革兰氏阴性菌引起的感染。。

“For healthcare teams treating patients with serious Gram-negative bacterial infections, the prospect of running out of effective treatment options is a daunting but very real threat,” said Yehuda Carmeli, Head, National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Medical Center, Israel, and an investigator in the REVISIT study.

以色列特拉维夫医学中心国家抗生素耐药性和感染控制研究所所长Yehuda Carmeli说：“对于治疗严重革兰氏阴性细菌感染患者的医疗团队来说，有效治疗选择的前景令人望而生畏，但却是实实在在的威胁。”。

“The approval of EMBLAVEO is welcome news for the infectious disease community and provides new hope to critically ill patients affected by antimicrobial resistance.”.

“EMBLAVEO的批准对传染病界来说是一个受欢迎的消息，并为受抗菌素耐药性影响的重症患者提供了新的希望。”。

Antimicrobial resistance (AMR) – when bacteria, viruses, fungi, and parasites change and find ways to resist the effects of antimicrobial drugs – is recognized as one of the biggest threats to global health.1 If AMR continues to rise unchecked, minor infections could become life-threatening, and many routine medical procedures such as caesarean sections and hip replacements could become too risky to perform.1 Multidrug-resistant Gram-negative bacteria are of particular concern due to the high rates of morbidity and mortality they cause.2,3 Metallo-β-lactamases (MBLs) are a type of enzyme produced by certain bacteria that can result in resistance to antibiotics, and MBL-producing Gram-negative bacteria are on the rise globally.4 Developing new treatments for infections caused by Gram-negative bacteria has been prioritized by the World Health Organization (WHO) as a critical area of focus due to their increasing spread.1,5.

抗菌药物耐药性（AMR）——当细菌、病毒、真菌和寄生虫发生变化并找到抵抗抗菌药物作用的方法时——被认为是对全球健康的最大威胁之一。1如果AMR继续不加控制地上升，轻微感染可能会危及生命，许多常规医疗程序（如剖腹产和髋关节置换术）可能变得风险太大而无法进行。1多重耐药革兰氏阴性菌因其引起的高发病率和死亡率而特别令人担忧。2,3金属β-内酰胺酶（MBLs）是由某些细菌产生的一种酶，可导致对抗生素的耐药性，产生MBL的革兰氏阴性菌在全球范围内呈上升趋势。4开发新的由于革兰氏阴性菌的传播越来越多，世界卫生组织（WHO）将革兰氏阴性菌感染的治疗列为重点领域。

“The European Medicines Agency’s accelerated review of EMBLAVEO reflects the urgent need for new treatments to address the threat of antimicrobial resistance,” said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer. “With this approval, Pfizer is proud to take another step forward in its commitment to developing and bringing breakthrough health solutions to patients impacted by serious infectious diseases around the world.”.

辉瑞首席国际商务官、执行副总裁亚历山大德日尔曼（AlexandreDeGermay）表示：“欧洲药品管理局（European Medicines Agency）对EMBLAVEO的加速审查反映出迫切需要新的治疗方法来应对抗菌素耐药性的威胁。”。“有了这一批准，辉瑞公司很自豪地迈出了新的一步，致力于为世界各地受严重传染病影响的患者开发和带来突破性的健康解决方案。”。

This approval is based on results from the previously reported Phase 3 program comprising the REVISIT (NCT03329092) and ASSEMBLE (NCT03580044) studies evaluating the efficacy, safety, and tolerability of EMBLAVEO in treating serious bacterial infections due to Gram-negative bacteria, including MBL-producing multidrug-resistant pathogens for which there are limited or no treatment options.6,7 Data support that EMBLAVEO is effective and well-tolerated, with no new safety findings and a similar safety profile to aztreonam alone.8.

该批准基于先前报道的第三阶段计划的结果，该计划包括REVIEW（NCT03329092）和ASSEMBLE（NCT03580044）研究，评估EMBLAVEO治疗革兰氏阴性菌引起的严重细菌感染的有效性，安全性和耐受性，包括产生MBL的多药耐药病原体，其治疗选择有限或没有治疗选择[6,7]。数据支持EMBLAVEO有效且耐受性良好，没有新的安全性发现，安全性与单独使用氨曲南相似。

The marketing authorization of EMBLAVEO is valid in all 27 European Union (EU) member states, as well as in Iceland, Liechtenstein, and Norway. Marketing authorization applications for EMBLAVEO are planned for submission in other countries.

EMBLAVEO的上市授权在所有27个欧盟（EU）成员国以及冰岛、列支敦士登和挪威均有效。EMBLAVEO的营销授权申请计划在其他国家提交。

About EMBLAVEO® (aztreonam-avibactam)

关于EMBLAVEO® （阿曲南阿维巴坦）

is indicated for the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), complicated urinary tract infections (cUTI), including pyelonephritis, and infections due to aerobic Gram-negative organisms with limited treatment options.

适用于治疗成人复杂腹腔感染（cIAI），医院获得性肺炎（HAP），包括呼吸机相关性肺炎（VAP），复杂尿路感染（cUTI），包括肾盂肾炎，以及有氧革兰氏阴性菌感染，治疗选择有限。

It combines aztreonam, a monobactam β-lactam, with avibactam, a recent broad-spectrum β-lactamase inhibitor.9,10 MBLs are a class of β-lactamase enzymes that are not inhibited by current β-lactamase inhibitors and hydrolyze nearly all β-lactam antibiotics, with an exception being monobactams such as aztreonam.

它将氨曲南（一种单巴坦β-内酰胺）与阿维巴坦（一种最近的广谱β-内酰胺酶抑制剂）结合在一起。9,10 MBL是一类β-内酰胺酶，不受当前β-内酰胺酶抑制剂的抑制，几乎可以水解所有β-内酰胺类抗生素，但氨曲南等单巴坦除外。

However, monobactams are degraded by other β-lactamases that are frequently co-produced with MBLs, limiting the clinical usefulness of aztreonam monotherapy.9.

然而，单巴坦被其他经常与MBL共同产生的β-内酰胺酶降解，限制了氨曲南单药治疗的临床实用性。

The combination of aztreonam with avibactam restores aztreonam’s activity against bacteria that co-produce MBLs and other β-lactamases and provides a well-tolerated and effective treatment option against multidrug-resistant Gram-negative bacteria.9 These multidrug-resistant Gram-negative bacteria include MBL-producing Enterobacterales, which have been highlighted as a critical priority pathogen by the WHO, and S.maltophilia..

氨曲南与阿维巴坦的组合恢复了氨曲南对共同产生MBL和其他β-内酰胺酶的细菌的活性，并为多重耐药革兰氏阴性菌提供了良好的耐受性和有效的治疗选择[9]。这些多重耐药革兰氏阴性菌包括产生MBL的肠杆菌，世卫组织和嗜麦芽病。

4,11 EMBLAVEO is the first β-lactam/β-lactamase inhibitor combination for treating serious bacterial infections in adult patients caused by multidrug-resistant Gram-negative bacteria, including MBL-producing bacteria, approved for use in the EU.

4,11 EMBLAVEO是第一种β-内酰胺/β-内酰胺酶抑制剂组合，用于治疗由多重耐药革兰氏阴性菌（包括产生MBL的细菌）引起的成人患者的严重细菌感染，已被批准在欧盟使用。

EMBLAVEO was jointly developed with AbbVie. Pfizer holds the global rights to commercialize this therapy outside of the U.S. and Canada, where the rights are held by AbbVie. Development of EMBLAVEO was also supported by public-private partnerships between Pfizer and the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under OTA number HHSO100201500029C; and through the EU’s Innovative Medicines Initiative (IMI) – a partnership between the EU and the European pharmaceutical industry – under a project called COMBACTE-CARE (Combatting Bacterial Resistance in Europe – Carbapenem Resistance).

EMBLAVEO是与AbbVie联合开发的。辉瑞拥有在美国和加拿大以外将这种疗法商业化的全球权利，AbbVie拥有这些权利。辉瑞公司与美国卫生与公众服务部之间的公私合作伙伴关系也支持EMBLAVEO的开发；战略准备和应对管理局；生物医学高级研究与发展局（BARDA），OTA编号HHSO100201500029C；并通过欧盟创新药物倡议（IMI）——欧盟和欧洲制药行业之间的合作伙伴关系——在一个名为COMBACTE-CARE的项目下（欧洲抗击细菌耐药性——碳青霉烯耐药性）。

The COMBACTE-CARE consortium is a unique public-private collaboration that unites the knowledge and capabilities of leading drug-resistant bacterial infection experts and is supported by the COMBACTE pan-European clinical and laboratory networks..

COMBACTE-CARE联盟是一个独特的公私合作组织，它将领先的耐药细菌感染专家的知识和能力结合在一起，并得到COMBACTE泛欧临床和实验室网络的支持。。

About Pfizer: Breakthroughs That Change Patients’ Lives

关于辉瑞：改变患者生活的突破

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development, and manufacture of health care products, including innovative medicines and vaccines.

在辉瑞，我们运用科学和全球资源为人们带来治疗方法，延长并显着改善他们的生活。我们努力为医疗保健产品（包括创新药物和疫苗）的发现、开发和制造制定质量、安全和价值标准。

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.

辉瑞公司的同事们每天都在发达市场和新兴市场开展工作，促进健康、预防、治疗和治愈，挑战我们这个时代最可怕的疾病。作为世界首屈一指的创新生物制药公司之一，我们与医疗保健提供者、政府和当地社区合作，支持和扩大全球可靠、负担得起的医疗保健服务。

For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com.

175年来，我们一直致力于为所有依赖我们的人带来改变。我们经常在我们的网站www.Pfizer.com上发布对投资者可能很重要的信息。