EMA同意复审Cubist制药ceftolozane/tazobactam市场授权申请

EMA同意复审Cubist制药ceftolozane/tazobactam市场授权申请

                               
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发布日期：2014-08-28  来源：dddmag  

欧洲药品管理局(EMA)同意复审Cubist制药公司的市场授权申请(MAA)，是关于正在研发中的治疗复杂尿路感染和腹腔感染的抗生素ceftolozane/tazobactam。

                               
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欧洲药品管理局(EMA)同意复审Cubist制药公司的市场授权申请(MAA)，是关于正在研发中的治疗复杂尿路感染和腹腔感染的抗生素ceftolozane/tazobactam。

欧盟委员会(EC)有望在2015年下半年批准ceftolozane/tazobactam上市。

该药的市场应用是基于两项III期临床试验的阳性结果。这两项临床试验都达到了EMA和FDA指定的主要终点。

在这些临床试验中，ceftolozane/tazobactam对革兰阴性菌具有显著效果，包括复杂感染病人体内的绿脓杆菌、大肠埃希菌及肺炎杆菌。

Cubist公司研发部副总监Steven Gilman认为，“公司很高兴收到ceftolozane/tazobactam的MAA回复，并期望与EMA积极配合这次重要的复审。随着我们公司在全球范围的拓展，Cubist公司始终恪守坚持研发新型抗生素的承诺，为面临各种感染的病人提供选择。”

EMA Accepts Ceftolozane/Tazobactam MAA for Review

                               
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(Source: NIH)Cubist Pharmaceuticals Inc. announced that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Application (MAA) for its investigational antibiotic ceftolozane/tazobactam. Cubist is seeking approval of ceftolozane/tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections, with a decision from the European Commission (EC) expected during the second half of 2015.

The MAA submission is based on positive data from two pivotal Phase 3 clinical trials of ceftolozane/tazobactam in complicated urinary tract infections and complicated intra-abdominal infections. These studies met both the EMA and U.S. Food and Drug Administration (FDA) specified primary endpoints. Results of the secondary analyses were consistent with and supportive of the primary outcomes. In the clinical trials, ceftolozane/tazobactam demonstrated activity against problematic Gram-negative bacteria, including Pseudomonas aeruginosa and extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E. coli) and Klebsiella pneumoniae in patients with complicated infections.

“We are pleased to receive MAA acceptance for ceftolozane/tazobactam and look forward to working with the EMA on this important review,” said Steven Gilman, executive vice president of Research and Development and Chief Scientific Officer of Cubist. “As we continue to expand globally, this advancement further positions Cubist to respond to growing health threats and reinforces our commitment to bring new antibiotics to patients worldwide facing serious infections, including those caused by Gram-negative bacteria.”

Prior to the EMA acceptance of the MAA, the FDA accepted the company’s New Drug Application (NDA) for ceftolozane/tazobactam with Priority Review and assigned an action date of December 21, 2014.

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