基于大量的临床Ⅲ期实验数据表明Avycaz用于治疗由特定的革兰氏阴性病原菌引起的肾盂肾炎导致的的严重的尿路感染取得了有效结果。FDA由此批准艾尔建的Avycaz治疗严重的尿路感染。

　　在大量的重复实验中表明，Avycaz有着较高的临床治愈率和最佳的微生物疗法。所有的实验包括因感染特定的病原菌而产生的超广谱β内酰胺酶和AmpCβ-内酰胺酶这两种酶类的的病人，在临床试验和微生物疗法这两种治疗措施有着相似的结果。

　　据悉，革兰氏阴性菌对很多抗生素产生了抗性，美国每年有4万人因此而感染。这些实验对于肾盂肾炎来说是一项重大的革新。

　　The US Food and Drug Administration has agreed to expand the label of Dublin, Ireland-based Allergan's Avycaz to include the treatment of complicated urinary tract infections (cUTI).

　　The decision is based on data from two Phase III clinical trials included in the submissions, which support the drug's use in cUTI, including pyelonephritis, caused by designated susceptible Gram-negative microorganisms.

　　In the RECAPTURE trial, Avycaz (ceftazidime and avibactam) was non-inferior to doripenem with regard to both primary endpoints (patient-reported symptomatic response at Day 5 and combined patient-reported symptomatic response and microbiological cure at the Test of Cure visit), while in the REPRISE study the treatment showed a higher combined clinical and microbiological cure rate versus best available therapy.

　　Both trials included a subset of patients with infections caused by pathogens producing certain ESBL groups and AmpC beta-lactamases in which the clinical and microbiological cure rates were similar to the overall results, the firm noted.

　　"Gram-negative pathogens are among the most urgent antibiotic resistance threats and cause more than 40,000 resistant infections in the US alone each year," said David Nicholson, chief R&D officer at Allergan.

　　"The inclusion of the REPRISE data in the label represents a significant advancement in the available data to support efficacy in cUTI patients infected with challenging pathogens, including certain ESBL and KPC-producing Enterobacteriaceae, reinforcing Allergan's leadership in responding to some of the most challenging infections facing our society today."

　　原文：http://www.pharmatimes.com/news/us_regulators_expand_use_of_allergans_antibiotic_1185496