AbbVie has announced that the US Food and Drug Administration (FDA) has approved its Pfizer-partnered Emblaveo (aztreonam-avibactam) to treat complicated intra-abdominal infections, including those caused by certain Gram-negative bacteria.
Emblaveo is now the first and only monobactam/beta-lactamase inhibitor combination antibiotic therapy approved by the regulator for this indication, according to AbbVie.
The intravenously-administered drug has been specifically authorised for use in combination with the antibiotic and antiprotozoal medication metronidazole to treat patients aged 18 years and older who have limited or no alternative options for complicated intra-abdominal infections, which occur within the abdominal cavity.
Declared by the World Health Organization (WHO) as one of the top ten threats to global health, antimicrobial resistance (AMR) occurs when bacteria, viruses, fungi and parasites change over time and resist the effects of antibiotics and other antimicrobial drugs. As a result, infections become harder to treat and the risk of disease spread, severe illness and death increases.
Multidrug-resistant Gram-negative bacteria are of particular concern due to the high rates of morbidity and mortality they cause.
Emblaveo, which is expected to be available in the US in the third quarter of 2025, is a fixed-dose combination of two components: aztreonam and avibactam. Aztreonam attaches to proteins on the surface of bacteria to prevent them from building their cell walls, which kills them. Meanwhile, avibactam blocks the action of enzymes that enable bacteria to break down and become resistant to aztreonam and other beta-lactam antibiotics.
Among the data supporting the FDA’s decision was clinical trial results from the phase 3 REVISIT study, which evaluated the efficacy, safety and tolerability of Emblaveo in serious infections due to Gram-negative bacteria, including Metallo-beta-lactamase-producing multidrug-resistant pathogens, for which there are limited or no treatment options.
Roopal Thakkar, executive vice president, research and development, chief scientific officer, AbbVie, 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 AMR.”
AbbVie holds the rights to commercialise Emblaveo in the US and Canada, while Pfizer is responsible for the drug’s commercialisation in all other areas.