AbbVie has announced the US Food and Drug Administration (FDA) approval of Emblaveo (aztreonam and avibactam) for the treatment of adults with complicated intra-abdominal infections with limited or no treatment options.
Emblaveo is a fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic.
It is now approved in combination with metronidazole for adults 18 and older with limited treatment options for complicated intra-abdominal infections (cIAI).
In 2019, the FDA granted the drug qualified infectious disease product (QIDP) and fast track designations.
In April 2024, the European Commission granted marketing authorisation for Emblaveo to treat adult patients with cIAI, hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis.
It is also approved for infections caused by aerobic Gram-negative organisms in adults with limited treatment options.
Emblaveo received marketing approval in the UK in June 2024, with other global submissions still ongoing.
The drug was jointly developed by AbbVie and Pfizer. The former is responsible for commercialisation in the US and Canada, while Pfizer is handling commercialisation in other regions.
AbbVie chief scientific officer research and development executive vice president Roopal Thakkar said: “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 approval is based on limited clinical safety and efficacy data for Emblaveo. It was also supported by clinical trial results from the Phase 3 REVISIT study.
REVISIT evaluated the efficacy, safety, and tolerability of the drug in treating serious infections for which limited, or no treatment options are available.
It enrolled 422 patients across 81 global locations. The primary endpoint was clinical cure at the test-of-cure visit in the intent-to-treat (ITT) population.
Secondary endpoints included 28-day mortality in the ITT population and safety in patients who received the study drug.
The trial showed the drug’s effectiveness in treating serious Gram-negative infections, including multidrug-resistant MBL-producing pathogens with limited treatment options.
Emblaveo is set for commercial availability in the US in Q3 2025.
