FDA Approves AbbVie's Combination Antibiotic Emblaveo for Complicated Intra-Abdominal Infections

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The US FDA today approved Emblaveo™ (aztreonam and avibactam; AbbVie), a novel fixed-dose, intravenous antibiotic combination, for the treatment of complicated intra-abdominal infections (cIAI) in adults with limited or no alternative treatment options.¹

The approval marks the first and only monobactam/β-lactamase inhibitor combination available for clinical use in the US. The therapy is expected to be available for commercial use in the US in the third quarter of 2025, according to a February 7, 2025, statement released by AbbVie.¹

Emblaveo, when used in combination with metronidazole (Metrogel®; Galderma Labs), is indicated for patients aged 18 years and older with cIAI caused by Gram-negative bacteria, including Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens.¹

The approval is based on limited clinical safety and efficacy data and aims to address the rising threat of antimicrobial resistance (AMR).¹ AMR is an escalating global health crisis, responsible for an estimated 1.14 million deaths worldwide in 2021 and projected to cause over 39 million deaths by 2050 if left unaddressed.²

"The continued evolution of antimicrobial resistance among Gram-negative bacteria has left some patients with little to no treatment options, resulting in extended hospital stays, additional morbidity and death," James A. McKinnell, MD, infectious disease specialist, Milefchik-Rand Medical Group, Torrance Memorial Medical Center, California, said in the press release.¹ "The approval of EMBLAVEO provides physicians a much-needed therapeutic option to help address some of the most difficult antimicrobial-resistant pathogens and provides doctors an opportunity to treat patients with these challenging infections."

Emblaveo consists of aztreonam, a monobactam antibiotic, and avibactam, a β-lactamase inhibitor that protects aztreonam from enzymatic degradation. This combination restores aztreonam’s activity against bacteria that produce Metallo-β-lactamases and serine β-lactamases, which are increasingly prevalent worldwide. The efficacy and safety of Emblaveo were supported by findings from the phase 3 REVISIT clinical trial, which assessed its use in patients with serious Gram-negative infections, including multidrug-resistant pathogens.¹

"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," Roopal Thakkar, MD, executive vice president, research & development, chief scientific officer, AbbVie, added in the press release.¹ "We're proud to offer this important novel treatment option to urgently address the significant threat of antimicrobial resistance."

References:

1. U.S. FDA Approves EMBLAVEO (aztreonam and avibactam) for the Treatment of Adults With Complicated Intra-Abdominal Infections With Limited or No Treatment Options. News release. Abbvie. February 7, 2025. https://news.abbvie.com/2025-02-07-U-S-FDA-Approves-EMBLAVEO-TM-aztreonam-and-avibactam-for-the-Treatment-of-Adults-With-Complicated-Intra-Abdominal-Infections-With-Limited-or-No-Treatment-Options
2. Naghavi, Mohsen, et al. "Global burden of bacterial antimicrobial resistance 1990–2021: A systematic analysis with forecasts to 2050." Lancet, vol. 404, no. 10459, 16 Sept. 2024, pp. 1199–1226.