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The U.S. Food and Drug Administration (FDA) has approved AbbVie and Pfizer’s antibiotic combination therapy of aztreonam and avibactam (branded Emblaveo) for use in patients with complicated intra-abdominal infections.

This new therapy, used in combination with metronidazole, targets patients with limited or no viable alternative treatment options in the management of complicated intra-abdominal infections.

Emblaveo is the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination authorized for intra-abdominal infections and is active against Gram-negative microbes including Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae complex, and Citrobacter freundii complex.

The drug, jointly developed by AbbVie and Pfizer, is a novel antibiotic combination featuring aztreonam, a monobactam β-lactam antibiotic, and avibactam, a broad-spectrum β-lactamase inhibitor.

This unique pairing ensures efficacy even in the presence of β-lactamases, including metallo-β-lactamases (MBLs), which typically confer resistance to many β-lactam antibiotics.

The significance of the aztreonam/avibactam combination becomes apparent in the fight against antimicrobial resistance, where it emerges as an effective treatment option against multidrug-resistant Gram-negative bacteria.

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FDA’s approval is based on results. from a Phase 3 study coded REVISIT where patients with complicated intra-abdominal infection demonstrated adjudicated clinical cure rate of 76·4% (159 of 208) when treated with aztreonam–avibactam combination (+metronidazole) compared to 74·0% (77 of 104) when managed with meropenem (with or without colistin).

"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," said 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."

It is expected EMBLAVEO will be available for commercial use in the U.S. in Q3 2025 and in other markets thereafter.

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