EC OKs AstraZeneca’s Antibiotic to Combat Drug Resistance
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The European Commission (EC) has granted marketing authorization for AstraZeneca’s Zavicefta (ceftazidime-avibactam), a new combination antibiotic for the treatment of patients with serious Gram-negative bacterial infections requiring hospitalization. Zavicefta was developed to address a need for new antibiotics to treat serious infections that are becoming increasingly resistant, such as multi-drug resistant P. aeruginosa, carbapenem-resistant Gram-negative pathogens, and ESBL-producing Enterobacteriaceae.

Ceftazidime-avibactam is being jointly developed by AstraZeneca and Allergan. AstraZeneca holds the global rights to commercialize Zavicefta, with the exception of North America, where the rights are held by Allergan.

The approval includes intravenous use of Zavicefta for the treatment of adult patients suffering from the following: complicated intra-abdominal infections; complicated urinary tract infections, including pyelonephritis; hospital-acquired pneumonia, including ventilator associated pneumonia; and, the treatment of aerobic Gram-negative infections in adult patients who have limited treatment options.

Zavicefta consists of a combination of avibactam and ceftazidime, a third-generation antipseudomonal cephalosporin. Avibactam is a broad-spectrum β-lactamase inhibitor, which protects ceftazidime against degradation by Class A, C and some D, β-lactamases. The addition of avibactam to ceftazidime protects ceftazidime from breakdown by β-lactamases. Zavicefta offers a differentiated profile versus existing treatment options in serious Gram-negative infections through its coverage of a broad range of species of Enterobacteriaceae, including those that produce ESBL and KPC, together with activity against difficult-to-treat P. aeruginosa.

In other news, the US Food and Drug Administration (FDA) has approved Allergan’s supplemental new drug application to update the label for Avycaz (ceftazidime and avibactam) with clinical data from a Phase III trial evaluating the safety and efficacy of Avycaz, in combination with metronidazole, for the treatment of complicated intra-abdominal infections caused by designated susceptible microorganisms. The approved label also contains data from a subset of patients in this trial with infections due to ceftazidime-nonsusceptible pathogens, as well as a subset who had pathogens producing certain extended-spectrum beta-lactamases (ESBLs).

Avycaz was first approved in the US in February 2015 for the treatment of adult patients with complicated intra-abdominal infections in combination with metronidazole, and complicated urinary tract infections, including pyelonephritis, caused by susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa.

Source: AstraZeneca and Allergan

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