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Sulbactam/Durlobactam: First Approval

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Abstract

Sulbactam/durlobactam (XACDURO®), is a co-packaged antibacterial product that has been developed by Entasis Therapeutics Inc. for the treatment of infections caused by Acinetobacter baumannii-calcoaceticus complex (ABC). Coadministration of durlobactam (a β-lactamase inhibitor with potent activity against a broad range of serine β-lactamases) with sulbactam (an established class A β-lactamase inhibitor with antibacterial activity against A. baumannii) prevents sulbactam degradation by ABC-produced β-lactamases. In May 2023, sulbactam/durlobactam was approved in the USA for use in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of ABC. This article summarizes the milestones in the development of sulbactam/durlobactam leading to this first approval for the treatment of infections caused by ABC.

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    Susan J. Keam

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Correspondence to Susan J. Keam.

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During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Susan J. Keam is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Keam, S.J. Sulbactam/Durlobactam: First Approval. Drugs 83, 1245–1252 (2023). https://doi.org/10.1007/s40265-023-01920-6

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