AbbVie has received US Food and Drug Administration (FDA) approval for Emblaveo (aztreonam and avibactam) to be used in conjunction with metronidazole for people aged 18 and over with complicated intra-abdominal infections (cIAI) and limited treatment options.
The approval marks the therapy as the first and only intravenous fixed-dose monobactam/β-lactamase inhibitor combo antibiotic.
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Emblaveo targets cIAI caused by Gram-negative microorganisms, including Escherichia coli and Klebsiella pneumoniae.
The therapy combines the monobactam antibiotic, aztreonam, and the β-lactamase inhibitor, avibactam, which protects against serine β-lactamase hydrolysis and restores activity against bacteria producing Metallo-β-lactamases (MBLs).
Previous outcomes related to aztreonam’s safety and efficacy for cIAI treatment support the therapy’s approval.
The approval was also backed by the clinical trial outcomes from the Phase III trial, REVISIT, which assessed the therapy’s tolerability, efficacy and safety against serious Gram-negative bacterial infections, including those resistant to multiple drugs.
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By GlobalDataAbbVie research and development executive vice-president and chief scientific officer Roopal Thakkar stated: “As bacteria evolve, industry, government and clinical experts must work together to ensure that the infectious disease community has the tools to advance public health.
“We’re proud to offer this important novel treatment option to urgently address the significant threat of antimicrobial resistance.”
The US regulator granted fast track status and qualified infectious disease product (QIDP) designation to the therapy in 2019.
Its commercial availability in the country is expected in the third quarter of this year.
Development of the therapy was a collaborative effort between AbbVie and Pfizer, with the former holding commercialisation rights in Canada and the US, and the latter handling other regions.
It also benefited from public-private collaborations, including support from the US Department of Health and Human Services, the Administration for Strategic Preparedness and Response, the Biomedical Advanced Research and Development Authority (BARDA) and the EU’s Innovative Medicines Initiative (IMI) under the COMBACTE-CARE project.
This consortium is backed by the COMBACTE pan-European clinical and laboratory networks.
In October 2024, the FDA approved AbbVie’s Vyalev for treating motor fluctuations in the adult population with advanced Parkinson’s disease.
