AstraZeneca announced that the EC has granted marketing authorisation for Zavicefta(ceftazidime-avibactam, previously known as CAZ AVI), a new combination antibiotic for the treatment of patients with serious Gram-negative bacterial infections requiring hospitalisation.
The approval includes intravenous use of Zavicefta for the treatment of adult patients suffering from complicated intra-abdominal infections (cIAI); Complicated urinary tract infections (cUTI), including pyelonephritis; hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP); and, the treatment of aerobic Gram-negative infections in adult patients who have limited treatment options.
Zavicefta has been developed in response to the urgent 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.
Hans Sijbesma, Managing Director, AstraZeneca Antibiotics Business Unit, said: “Zavicefta is an important addition to the arsenal of antibiotics in the global fight against antimicrobial resistance. Effective treatment options are rapidly running out for serious Gram-negative infections. Zavicefta helps bridge that gap and allows a broad population of patients across Europe to benefit from this new medicine.”
The approval is based on data from an extensive clinical trial programme demonstrating the safety and efficacy ofZavicefta. The data include results from three Phase III studies in cIAI; Phase II and III studies in cUTI; and data from a Phase I study for HAP/VAP. An additional Phase III study evaluating the efficacy of Zavicefta in ceftazidime-resistant cUTI and cIAI, compared to the best available therapy, was also included in the submission.
The EC marketing authorisation applies to all 28 EU member countries plus Iceland, Norway and Liechtenstein.
Zavicefta (ceftazidime-avibactam) is a combination antibiotic that has been developed to treat serious Gram-negative bacterial infections. It consists of a combination of avibactam and ceftazidime – a third generation antipseudomonal cephalosporin with a well-established efficacy and safety profile. Avibactam is a first-in-class 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.
Ceftazidime-avibactam is being jointly developed by AstraZeneca and Allergan. AstraZeneca holds the global rights to commercialise Zavicefta, with the exception of North America, where the rights are held by Allergan.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – oncology; respiratory and autoimmunity; and cardiovascular and metabolic disease. We are also active in infection, neuroscience and inflammatory diseases through collaborations with others. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com
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1. 1. European Centre for Disease Prevention and Control (ECDC). Technical Report: the bacterial challenge: time to react. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2009/11/WC500008770.pdf Accessed April 2016.
2. Review on AMR, Antimicrobial resistance: Tackling a crisis for the health and wealth of nations, 2014.