决默沙东Zerbaxa，阿特维斯新型 产品Avycaz喜获FDA批准

全球仿制药巨头阿特维斯（Actavis）近日宣布，新型抗生素产品Avycaz获得FDA批准，用于复杂性腹腔内感染 (cIAI)（联合甲硝唑）及复杂性尿路感染 (cUTI) 的治疗。此前，FDA已授予Avycaz合格传染病产品 (QIDP)资格，并根据II期临床数据进行了优先审查，因此Avycaz应保守用于有限或无替代治疗方案的患者群体。该药的III期临床正在进行中，相关数据将用于支持Avycaz的标签扩展。

Avycaz（ceftazidime-avibactam，头孢他啶-阿维巴坦）是由一种广谱头孢菌素（ceftazidime）与一种新型β-内酰胺酶抑制剂 (avibactam) 组成的复方产品，开发用于治疗革兰氏阴性细菌感染，包括对现有抗生素产品有耐药性的广谱β-内酰胺酶及肺炎克雷伯杆菌碳青霉烯酶。Avycaz原本由森林实验室（Forest Lab）和阿斯利康联合开发，但去年2月，阿特维斯耗资250亿美元收购Forest Lab后将Avycaz收入囊中。根据协议，阿特维斯拥有Avycaz在北美市场的权利，阿斯利康拥有Avycaz在全球其他地区的权利。

Avycaz vs Zerbaxa——阿特维斯 vs 默沙东

值得一提的是，Avycaz的获批，也意味着阿特维斯手握了一支能与默沙东抗生素新产品Zerbaxa相抗衡的武器。Zerbaxa原本由抗生素巨头Cubist开发，默沙东于2014年底耗资95亿美元收购了Cubist，Zerbaxa便是该笔收购的关键因素。同月，收购尚未完成之际，Zerbaxa便获得了FDA批准。业界此前预测，Zerbaxa的年销售峰值将超过10亿美元。

Zerbaxa药物组成与Avycaz相似，也是由一种新型头孢菌素（ceftolozane）和一种β-内酰胺酶抑制剂（tazobactam，他唑巴坦）组成的复方产品，获批的适应症也是复杂性腹腔内感染（cIAI）和复杂性尿路感染（cUTI），但Zerbaxa未包含附加警告信息。目前，阿特维斯与阿斯利康正联手开展Avycaz III期临床，预计在年底完成。届时，阿特维斯将提交申请扩大Avycaz药物标签，而阿斯利康将利用这些数据支持Avycaz在全球其他地区的监管申请。

当前，面对日趋严峻的“抗菌”形势，一些国家已经开始采取激励措施，鼓励新抗生素的研发。美国于2012年7月通过了《鼓励开发抗生素法案》(GAIN)，根据规定，符合标准的抗生素药物将获得额外五年的市场独占权，以帮助开发者收回投资。Zebraxa便是根据《鼓励开发抗生素法案》(GAIN)批准治疗革兰氏阴性菌的首个新抗生素产品。据估计，在美国每年由革兰氏阴性菌感染导致的病例高达200万例，死亡病例23000例，导致的直接医疗费用高达200亿美元。（生物谷Bioon.com）

英文原文：Actavis wins FDA approval for a new 'superbug' antibiotic

Actavis wins FDA approval for a new 'superbug' antibiotic

Actavis ($ACT) won the FDA's blessing for a new combination antibiotic treatment targeting drug-resistant infections, setting the stage for a showdown with Merck ($MRK) and its $9.5 billion splash into the field.

The drug, Avycaz, is a combination of the approved cephalosporin agent ceftazidime and avibactam, a new beta-lactamase inhibitor designed to help the former ingredient escape the defenses of dangerous pathogens. Avycaz, picked up in Actavis' $28 billion acquisition of Forest Laboratories, is now approved to treat complicated urinary tract and intra-abdominal infections caused by Gram-negative bacteria, which have few treatment options.

With an eye on the worsening scourge of treatment-resistant bugs, the FDA cleared Avycaz on Phase II data alone, giving Actavis a priority review and indicating the drug only for patients with limited or no other alternatives.

Actavis holds the American rights to Avycaz while AstraZeneca ($AZN) controls the drug in the rest of the world, and the pair are working through Phase III trials set to wrap up this year. Once they have late-stage data, Actavis will hand it into the FDA in hopes of expanding the drug's label, and AstraZeneca will use it to support global approvals.

Now Avycaz will contend with Merck's recently approved Zerbaxa, which also combines a cephalosporin with a beta-lactamase inhibitor. That drug, picked up in the company's acquisition of Cubist Pharmaceuticals, is approved for complicated urinary tract and intra-abdominal infections with no caveats, and analysts expect it to bring in peak sales above $1 billion a year.

Actavis sees similar promise for itself in the antibiotic space, last year trading $675 million for Durata Therapeutics to help build out its stable of treatments for infectious disease. The company is following a trend among the world's largest drugmakers, whose history of inattention to antibiotic R&D is in part responsible for the current increase in demand--and market opportunity--for anti-infectives. Now, buoyed by government incentives, Big Pharma is creeping back into the space.

"The FDA approval of Avycaz is an important step forward in enhancing our ability to respond to serious infections caused by difficult to treat Gram-negative pathogens," Actavis Executive Vice President David Nicholson said in a statement. "... We were very pleased to be working with the FDA to advance the approval of Avycaz as quickly as possible to make this important new treatment option available to physicians and patients at the earliest possible time."