Aztreonam/avibactam: Difference between revisions

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{{Orphan|date=November 2023}}
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{{Short description|Combination antibiotic medication}}
{{Use dmy dates|date=April 2024}}
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| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
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| legal_US_comment =
| legal_US_comment = Rx-only
| legal_EU = <ref name="Emblaveo PI">{{cite web | title=Emblaveo Product information | website=Union Register of medicinal products | date=22 April 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1808.htm | access-date=22 April 2024}}</ref>
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| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
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'''Aztreonam/avibactam''' is a combination of [[aztreonam]] and [[avibactam]] developed by [[AbbVie]] for "complicated [[Gram-negative]] infections".<ref>{{cite web |title=Pipeline |url=https://www.abbvie.com/science/pipeline.html |website=AbbVie |access-date=25 November 2023}}</ref><ref>{{cite journal |last1=Sader |first1=Helio S |last2=Castanheira |first2=Mariana |last3=Kimbrough |first3=John H |last4=Kantro |first4=Valerie |last5=Mendes |first5=Rodrigo E |title=Aztreonam/avibactam activity against a large collection of carbapenem-resistant Enterobacterales (CRE) collected in hospitals from Europe, Asia and Latin America (2019–21) |journal=JAC-Antimicrobial Resistance |date=22 March 2023 |volume=5 |issue=2 |pages=dlad032 |doi=10.1093/jacamr/dlad032 |pmid=36968952 |pmc=10032302 |issn=2632-1823}}</ref><ref>{{cite journal |last1=Livermore |first1=David M. |last2=Mushtaq |first2=Shazad |last3=Vickers |first3=Anna |last4=Woodford |first4=Neil |title=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 |journal=International Journal of Antimicrobial Agents |date=May 2023 |volume=61 |issue=5 |pages=106776 |doi=10.1016/j.ijantimicag.2023.106776|pmid=36893810 |s2cid=257428399 |doi-access=free }}</ref> Drug resistance to the combination has been reported.<ref>{{cite journal |last1=Nordmann |first1=Patrice |last2=Yao |first2=Yancheng |last3=Falgenhauer |first3=Linda |last4=Sadek |first4=Mustafa |last5=Imirzalioglu |first5=Can |last6=Chakraborty |first6=Trinad |title=Recent Emergence of Aztreonam-Avibactam Resistance in NDM and OXA-48 Carbapenemase-Producing Escherichia coli in Germany |journal=Antimicrobial Agents and Chemotherapy |date=18 October 2021 |volume=65 |issue=11 |pages=e0109021 |doi=10.1128/aac.01090-21|pmid=34424048 |s2cid=237268078 |pmc=8522741 }}</ref>
'''Aztreonam/avibactam''', sold under the brand name '''Emblaveo''', is a combination of [[aztreonam]], a [[β-lactam antibiotic]], and [[avibactam]], a [[β-Lactamase inhibitor]], developed by [[AbbVie]] for aerobic [[Gram-negative]] infections.<ref name="Emblaveo PI" /><ref>{{cite web |title=Pipeline |url=https://www.abbvie.com/science/pipeline.html |website=AbbVie |access-date=25 November 2023}}</ref><ref>{{cite journal |last1=Sader |first1=Helio S |last2=Castanheira |first2=Mariana |last3=Kimbrough |first3=John H |last4=Kantro |first4=Valerie |last5=Mendes |first5=Rodrigo E |title=Aztreonam/avibactam activity against a large collection of carbapenem-resistant Enterobacterales (CRE) collected in hospitals from Europe, Asia and Latin America (2019–21) |journal=JAC-Antimicrobial Resistance |date=22 March 2023 |volume=5 |issue=2 |pages=dlad032 |doi=10.1093/jacamr/dlad032 |pmid=36968952 |pmc=10032302 |issn=2632-1823}}</ref><ref>{{cite journal |last1=Livermore |first1=David M. |last2=Mushtaq |first2=Shazad |last3=Vickers |first3=Anna |last4=Woodford |first4=Neil |title=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 |journal=International Journal of Antimicrobial Agents |date=May 2023 |volume=61 |issue=5 |pages=106776 |doi=10.1016/j.ijantimicag.2023.106776|pmid=36893810 |s2cid=257428399 |doi-access=free }}</ref> Drug resistance to the combination has been reported.<ref>{{cite journal |last1=Nordmann |first1=Patrice |last2=Yao |first2=Yancheng |last3=Falgenhauer |first3=Linda |last4=Sadek |first4=Mustafa |last5=Imirzalioglu |first5=Can |last6=Chakraborty |first6=Trinad |title=Recent Emergence of Aztreonam-Avibactam Resistance in NDM and OXA-48 Carbapenemase-Producing Escherichia coli in Germany |journal=Antimicrobial Agents and Chemotherapy |date=18 October 2021 |volume=65 |issue=11 |pages=e0109021 |doi=10.1128/aac.01090-21|pmid=34424048 |s2cid=237268078 |pmc=8522741 }}</ref>

The combination was approved for medical use in the European Union in April 2024.<ref name="Emblaveo PI" />

== Medical uses ==
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.<ref name="Emblaveo PI" /> It is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.<ref name="Emblaveo PI" />


== Society and culture ==
== Society and culture ==
=== Legal status ===
=== Legal status ===
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.<ref name="Emblaveo EPAR" /> The applicant for this medicinal product is Pfizer Europe MA EEIG.<ref name="Emblaveo EPAR">{{cite web | title=Emblaveo EPAR | website=European Medicines Agency | date=21 March 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/emblaveo | access-date=23 March 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref>
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.<ref name="Emblaveo EPAR" /> The applicant for this medicinal product is Pfizer Europe MA EEIG.<ref name="Emblaveo EPAR">{{cite web | title=Emblaveo EPAR | website=European Medicines Agency | date=21 March 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/emblaveo | access-date=23 March 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> The combination was approved for medical use in the European Union in April 2024.<ref name="Emblaveo PI" />


==References==
==References==
{{reflist}}
{{reflist}}

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[[Category:Combination antibiotics]]
[[Category:Combination antibiotics]]

Revision as of 20:11, 22 April 2024

Aztreonam/avibactam
Combination of
Aztreonamβ-lactam antibiotic
Avibactamβ-Lactamase inhibitor
Clinical data
Trade namesEmblaveo
ATC code
  • None
Legal status
Legal status
  • US: Rx-only
  • EU: [1]

Aztreonam/avibactam, sold under the brand name Emblaveo, is a combination of aztreonam, a β-lactam antibiotic, and avibactam, a β-Lactamase inhibitor, developed by AbbVie for aerobic Gram-negative infections.[1][2][3][4] Drug resistance to the combination has been reported.[5]

The combination was approved for medical use in the European Union in April 2024.[1]

Medical uses

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.[1] It is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.[1]

Society and culture

Legal status

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.[6] The applicant for this medicinal product is Pfizer Europe MA EEIG.[6] The combination was approved for medical use in the European Union in April 2024.[1]

References

  1. ^ a b c d e f "Emblaveo Product information". Union Register of medicinal products. 22 April 2024. Retrieved 22 April 2024.
  2. ^ "Pipeline". AbbVie. Retrieved 25 November 2023.
  3. ^ Sader HS, Castanheira M, Kimbrough JH, Kantro V, Mendes RE (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.
  4. ^ Livermore DM, Mushtaq S, Vickers A, Woodford N (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.
  5. ^ Nordmann P, Yao Y, Falgenhauer L, Sadek M, Imirzalioglu C, Chakraborty T (18 October 2021). "Recent Emergence of Aztreonam-Avibactam Resistance in NDM and OXA-48 Carbapenemase-Producing Escherichia coli in Germany". Antimicrobial Agents and Chemotherapy. 65 (11): e0109021. doi:10.1128/aac.01090-21. PMC 8522741. PMID 34424048. S2CID 237268078.
  6. ^ a b "Emblaveo EPAR". European Medicines Agency. 21 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.