The combination was approved for medical use in the European Union in April 2024,[4][8] in the United Kingdom in June 2024,[9] and in the United States in February 2025.[9]
In the EU and the UK, aztreonam/avibactam isindicated 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 March 2024, theCommittee for Medicinal Products for Human Use (CHMP) of theEuropean 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][10] 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]
^abc"Emblaveo EPAR".European Medicines Agency. 21 March 2024.Archived from the original on 23 March 2024. Retrieved23 March 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^Carmeli, Yehuda; Cisneros, José Miguel; Paul, Mical; Daikos, George L.; Wang, Minggui; Torre-Cisneros, Julian; et al. (February 2025). "Aztreonam-avibactam versus meropenem for the treatment of serious infections caused by Gram-negative bacteria (REVISIT): a descriptive, multinational, open-label, phase 3, randomised trial". The Lancet Infectious Diseases.25 (2):218–230.doi:10.1016/S1473-3099(24)00499-7.ISSN1474-4457.PMID39389071.
Clinical trial numberNCT03329092 for "A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria. (REVISIT)" atClinicalTrials.gov
