The U.S. Food and Drug Administration (FDA) has approved AbbVie’s EMBLAVEO (aztreonam and avibactam) as the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic. It is approved in combination with metronidazole, for patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI), including those caused by susceptible Gram-negative microorganisms.

Approval of this indication is based on clinical safety and efficacy data for EMBLAVEO.

“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,” explained James A. McKinnell, M.D., infectious disease specialist, Milefchik-Rand Medical Group, Torrance Memorial Medical Center in Torrance, California. “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.”

“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,” said Roopal Thakkar, M.D., executive vice president, research & development, chief scientific officer, AbbVie. “We’re proud to offer this important novel treatment option to urgently address the significant threat of antimicrobial resistance.”

EMBLAVEO combines two components: 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 a type of enzyme produced by certain bacteria that can become resistant to antibiotics and are on the rise globally.

The approval of EMBLAVEO was supported by prior findings regarding the efficacy and safety of aztreonam for the treatment of cIAI. It was also supported by clinical trial results from the Phase 3 REVISIT study, which evaluated the efficacy, safety, and tolerability of EMBLAVEO for the treatment of serious infections due to Gram-negative bacteria, including MBL-producing multidrug-resistant pathogens, for which there are limited or no treatment options.

In 2019, the FDA granted Qualified Infectious Disease Product (QIDP) Designation and Fast Track Designation for EMBLAVEO.

EMBLAVEO will be available for commercial use in the U.S. in Q3 2025.