Drugmaker AbbVie announced late last week that the US Food and Drug Administration (FDA) has approved Emblaveo (aztreonam-avibactam) for treating complicated intra-abdominal infections (cIAIs).
The FDA approved the monobactam/beta-lactamase inhibitor combination for use in combination with metronidazole to treat patients who have limited or no treatment options for cIAIs caused by gram-negative bacteria, including Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens.
The combination of aztreonam with avibactam aims to restore aztreonam's activity against gram-negative bacteria that are becoming increasingly resistant to antibiotics. Specifically, it targets gram-negative pathogens that carry two defense mechanisms—metallo-beta-lactamase (MBL) enzymes and other beta-lactamase enzymes—that confer resistance to nearly all currently available antibiotics. While aztreonam can evade degradation by MBLs on its own, the addition of avibactam helps restore its activity against other beta-lactamases.
As a potential weapon against infections with limited treatment options, Emblaveo was granted Qualified Infectious Disease Product and Fast Track designations by the FDA in 2019 to speed up development and review.
Novel treatment option
"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 of research & development and chief scientific officer at AbbVie, said in a press release. "We're proud to offer this important novel treatment option to urgently address the significant threat of antimicrobial resistance."
The approval was based on prior findings regarding the safety of aztreonam for treating cIAIs, as well as the results of the phase 3 REVISIT trial, which found that Emblaveo had similar cure rates in patients with cIAI or hospital-acquired or ventilator-associated pneumonia (HAP-VAP) compared with meropenem with or without colistin.
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.
Emblaveo was jointly developed by Pfizer and AbbVie. In April 2024, the European Medicines Agency approved the drug for treatment of cIAIs, HAP-VAP, and complicated urinary tract infections. AbbVie hold the rights for commercialization in the United States and Canada, while Pfizer holds commercialization rights in all other countries.