Aztreonam/avibactam

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Aztreonam/avibactam
Aztreonam and avibactam.svg
Combination of
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
  • None
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 was developed by AbbVie and Pfizer, [4] [5] [6] and is a combination of aztreonam, a monobactam antibacterial, and avibactam, a non-beta-lactam beta-lactamase inhibitor. [4] [7]

Contents

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]

Medical uses

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]

Society and culture

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] [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]

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. [9] [11]

References

  1. ↑ "Emblaveo 1.5 g/0.5 g powder for concentrate for solution for infusion". (emc). 21 August 2024. Retrieved 11 February 2025.
  2. 1 2 "Emblaveo- aztreonam and avibactam powder, for solution". DailyMed. 7 February 2025. Retrieved 2 April 2025.
  3. 1 2 3 "Emblaveo EPAR". European Medicines Agency. 21 March 2024. Archived from the original on 23 March 2024. Retrieved 23 March 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  4. 1 2 3 4 5 6 7 8 "Emblaveo Product information". Union Register of medicinal products. 22 April 2024. Retrieved 22 April 2024.
  5. ↑ Sader, Helio S; Castanheira, Mariana; Kimbrough, John H; Kantro, Valerie; Mendes, Rodrigo E (22 March 2023). "Aztreonam/avibactam activity against a large collection of carbapenem-resistant Enterobacterales (CRE) collected in hospitals from Europe, Asia and Latin America (2019–21)". JAC-Antimicrobial Resistance. 5 (2) dlad032. doi:10.1093/jacamr/dlad032. ISSN   2632-1823. PMC   10032302 . PMID   36968952.
  6. ↑ Livermore, David M.; Mushtaq, Shazad; Vickers, Anna; Woodford, Neil (May 2023). "Activity of aztreonam/avibactam against metallo-β-lactamase-producing Enterobacterales from the UK: Impact of penicillin-binding protein-3 inserts and CMY-42 β-lactamase in Escherichia coli". International Journal of Antimicrobial Agents. 61 (5) 106776. doi: 10.1016/j.ijantimicag.2023.106776 . PMID   36893810. S2CID   257428399.
  7. ↑ Al Musawa, Mohammed; Bleick, Callan R.; Herbin, Shelbye R.; Caniff, Kaylee E.; Van Helden, Sean R.; Rybak, Michael J. (2024). "Aztreonam–avibactam: The dynamic duo against multidrug-resistant gram-negative pathogens". Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy. 44 (12): 927–938. doi:10.1002/phar.4629. ISSN   1875-9114. PMC   11687205 . PMID   39601336.
  8. ↑ "European Commission Approves Pfizer's Emblaveo for Patients with Multidrug-Resistant Infections and Limited Treatment Options". Pfizer (Press release). 22 April 2024. Retrieved 22 April 2024.
  9. 1 2 3 "U.S. FDA Approves Emblaveo (aztreonam and avibactam) for the Treatment of Adults With Complicated Intra-Abdominal Infections With Limited or No Treatment Options" (Press release). AbbVie. 7 February 2025. Retrieved 11 February 2025– via PR Newswire.
  10. ↑ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2024". European Medicines Agency (Press release). 22 March 2024. Retrieved 13 June 2024.
  11. ↑ 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. ISSN   1474-4457. PMID   39389071.
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