AbbVie announced the U.S. Food and Drug Administration (FDA) approval of EMBLAVEO™ (aztreonam and avibactam), marking a pivotal step in the fight against antimicrobial resistance (AMR). EMBLAVEO is the first and only fixed-dose intravenous monobactam/β-lactamase inhibitor combination antibiotic approved for patients 18 years and older with limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI). The therapy is indicated for use in combination with metronidazole and is effective against a range of Gram-negative microorganisms, including Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens.

This approval addresses a critical public health need as Gram-negative bacterial infections, which are highly resistant to existing antimicrobial therapies, represent one of the most challenging threats in healthcare. Antimicrobial resistance contributes to significant morbidity and mortality worldwide, with over 1.14 million deaths attributed to bacterial AMR in 2021 alone. Without urgent intervention, AMR could result in more than 39 million deaths globally by 2050.

Dr. James A. McKinnell, an infectious disease specialist at Torrance Memorial Medical Center, emphasized the importance of this breakthrough: “The continued evolution of antimicrobial resistance among Gram-negative bacteria has left some patients with little to no treatment options. The approval of EMBLAVEO provides physicians with a much-needed therapeutic option to address some of the most difficult antimicrobial-resistant pathogens.”

EMBLAVEO combines aztreonam, a monobactam antibiotic, with avibactam, a β-lactamase inhibitor that restores the efficacy of aztreonam against Metallo-β-lactamases (MBLs) and serine β-lactamases. These enzymes, produced by certain bacteria, are on the rise globally and render many antibiotics ineffective. EMBLAVEO’s approval was supported by prior evidence on the efficacy of aztreonam for cIAI treatment, as well as results from the Phase 3 REVISIT trial, which demonstrated the therapy's safety, efficacy, and tolerability against multidrug-resistant Gram-negative pathogens.

“As bacteria evolve, collaboration among industry, government, and clinical experts is essential to advance public health,” said Dr. Roopal Thakkar, Executive Vice President of Research & Development and Chief Scientific Officer at AbbVie. “We are proud to offer EMBLAVEO as an innovative treatment option to urgently address the significant threat of antimicrobial resistance.”

In recognition of its potential to combat AMR, EMBLAVEO received Qualified Infectious Disease Product (QIDP) Designation and Fast Track Designation from the FDA in 2019. These designations provided priority review, regulatory exclusivity extension, and support for expedited development to address serious medical conditions with unmet needs.

EMBLAVEO is expected to be commercially available in the United States in Q3 2025, offering healthcare providers a vital tool to manage challenging Gram-negative infections and combat the escalating global threat of AMR.