FDA Approves Emblaveo Combination Antibiotic Therapy for Complicated Intra-Abdominal Infections

The FDA has approved Abbvie’s aztreonam and avibactam monobactam/β-lactamase inhibitor combination antibiotic therapy, the first of its kind, under the name Emblaveo for treating complicated intra-abdominal infections (cIAI), including those caused by Gram-negative bacteria.¹

Emblaveo was approved in combination with metronidazole, for adult who have limited or no alternative options for the treatment of cIAI including those caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. The therapy will be available for commercial use in the United States in the third quarter of 2025.

"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 a statement.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 combines aztreonam, a monobactam antibiotic, and avibactam, a β-lactamase inhibitor that protects aztreonam from serine β-lactamase hydrolysis and restores its activity against bacteria that co-produce Metallo-β-lactamases (MBLs) and serine β-lactamases. MBLs are enzymes produced by certain bacteria that can become resistant to antibiotics, which are becoming more prevalent.

Emblaveo was approved based off of prior findings supporting the efficacy and safety of aztreonam for the treatment of cIAI and clinical trial results from the Phase 3 REVISIT study, which evaluated the efficacy, safety, and tolerability which demonstrating its efficacy in treating serious infections due to Gram-negative bacteria, including MBL-producing multidrug-resistant pathogens. Gram-negative bacterial infection are challenging for healthcare professionals to control due to rising antimicrobial resistance (AMR), which is considered an urgent global public health threat.²

"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.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.