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Combination of | |
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Aztreonam | Monobactam antibacterial |
Avibactam | Beta-lactamase inhibitor |
Clinical data | |
Trade names | Emblaveo |
AHFS/Drugs.com | Monograph |
MedlinePlus | a625054 |
License data | |
Routes of administration | Intravenous |
ATC code |
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Legal status | |
Legal status | |
Identifiers | |
KEGG |
Aztreonam/avibactam, sold under the brand name Emblaveo, is a fixed-dose combination antibacterial medication used for the treatment of aerobic Gram-negative infections. [4] It is a combination of aztreonam, a monobactam antibacterial; and avibactam, a beta-lactamase inhibitor. [4] It was developed by AbbVie and Pfizer. [4] [5] [6]
The combination was approved for medical use in the European Union in April 2024, [4] [7] in the United Kingdom in June 2024, [8] and in the United States in February 2025. [8]
In the EU and the UK, aztreonam/avibactam is indicated for the treatment of complicated intra-abdominal infection; hospital-acquired pneumonia, including ventilator-associated pneumonia; or complicated urinary tract infection, including pyelonephritis. [4] It is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. [4]
In the US, aztreonam/avibactam, in combination with metronidazole, is indicated in people aged 18 years of age and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections including those caused by the following susceptible gram-negative microorganisms: Escherichia coli , Klebsiella pneumoniae , Klebsiella oxytoca , Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens . [2]
In March 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Emblaveo, intended for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections due to aerobic Gram-negative organisms in people with limited treatment options. [3] [9] The applicant for this medicinal product is Pfizer Europe MA EEIG. [3] The combination was approved for medical use in the European Union in April 2024. [4]
The Food and Drug Administration (FDA) approved Emblaveo in February 2025 largely based on the results of the Phase III open-label randomized REVISIT trial. [8] [10]