Officials with AbbVie have announced that the FDA has approved aztreonam and avibactam (Emblaveo; AbbVie), as the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic.1
The combination antibiotic is approved in adult patients in combination with metronidazole, for patients who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI), including those caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens.
The approval was based on data from the phase 3 REVISIT active-controlled, central assessor-blinded, multicenter trial that randomly assigned 422 patients to either the combination treatment or the combination of meropenem ± colistin in patients with cIAI or hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (not an approved indication for Emblaveo).
The primary end point was clinical cure at the test-of-cure visit in the intent-to-treat (ITT) population. Secondary end points included 28-day mortality in the ITT population, and safety in patients in the ITT population who received the study drug.
The researchers noted that 68% of patients in the aztreonam-avibactam group and 65.7% in the meropenem group had clinical cure at the test-of-cure visit (treatment difference 2.7% [95% confidence interval, 6.6-12.4]). Adjudicated clinical cure rates for patients with cIAI were 76.4% in the aztreonam-avibactam group and 74.0% in the meropenem group.2
“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, infectious disease specialist, Milefchik-Rand Medical Group, Torrance Memorial Medical Center in Torrance, CA, said in a press release about the approval. “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.”
In 2019, the FDA granted Qualified Infectious Disease Product (QIDP) designation and Fast Track designation for Emblaveo. The QIDP designation provides certain incentives for the development of new antibiotics, including priority review and eligibility for the FDA’s Fast Track designation, and a 5-year regulatory exclusivity extension.
References
- AbbVie. U.S. FDA approves EMBLAVEO™ (aztreonam and avibactam) for the treatment of adults with complicated intra-abdominal infections with limited or no treatment options [press release]. February 7, 2025. Accessed February 17, 2025. https://news.abbvie.com/2025-02-07-U-S-FDA-Approves-EMBLAVEO-TM-aztreonam-and-avibactam-for-the-Treatment-of-Adults-With-Complicated-Intra-Abdominal-Infections-With-Limited-or-No-Treatment-Options
- Aztreonam-avibactam versus meropenem for the treatment of serious infections caused by Gram-negative bacteria (REVISIT): a descriptive, multinational, open-label, phase 3, randomised trial. Carmeli Y, et al. Lancet Infect Dis. 2025;25:218-230.