FDA approves Emblaveo for complicated intra-abdominal infections
Key takeaways:
- Emblaveo is the first monobactam/beta-lactamase inhibitor and antibiotic combination approved for this condition.
- The approval was based on results from the phase 3 REVISIT trial.
The FDA has approved the intravenous antibiotic Emblaveo for adults with complicated intra-abdominal infections who have limited treatment options.
Emblaveo (aztreonam and avibactam), is the first monobactam antiobiotic andbeta-lactamase inhibitor combination approved for this condition, according to a press release from AbbVie.
The approval is for Emblaveo in conjunction with metronidazole for adults over the age of 18 infected with gram-negative microorganisms such as Escherichia coli, Klebisella pneumoniae, Klebisella oxytoca, Entrobacter colacae complex, Citrobacter freundii complex and Serratia marcescens, for which there are few or no alternative treatment options.
"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, an infectious disease specialist with Milefchik-Rand Medical Group at Torrance Memorial Medical Center, said in the release. "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 works by combining aztreonam, a monobactam antibiotic, with avibactam, a beta-lactamase inhibitor. This combination improves the efficacy of aztreonam against Metallo-beta-lactamase-producing bacteria, which can be resistant to most antibiotics.
Gram-negative bacteria that cause complicated intra-abdominal infections are difficult to manage due to their high antimicrobial resistance, which can render most antibiotics ineffective and can lead to a higher likelihood of death, according to the press release. More than 39 million deaths are predicted to be caused by antimicrobial resistant bacteria by the year 2050.
Approval of Emblaveo was based on data from the randomized, active-controlled, central assessor-blinded, multicenter, phase 3 REVISIT,trial, which demonstrated the efficacy, safety and tolerability of the medication in treating serious gram-negative infections. The FDA’s Qualified Infectious Disease Product and Fast Track designation was awarded to Emblaveo in 2019. It is scheduled to become available commercially in late 2025.