The U.S. Food and Drug Administration (FDA) has approved EMBLAVEO, a combination of aztreonam and avibactam, for treating adults with complicated intra-abdominal infections (cIAI). This new therapy is the first monobactam/β-lactamase inhibitor combination antibiotic to receive FDA approval for such infections, particularly those caused by Gram-negative bacteria. The approval is based on limited clinical safety and efficacy data.
Dr. James A. McKinnell, an infectious disease specialist at Milefchik-Rand Medical Group, emphasized the significance of this development: "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." He added that EMBLAVEO provides a much-needed option for addressing difficult antimicrobial-resistant pathogens.
Antimicrobial resistance (AMR) poses a significant global health threat, potentially leading to over 39 million deaths worldwide by 2050 if unaddressed. In 2021 alone, bacterial AMR was linked to approximately 1.14 million deaths globally. The FDA has prioritized developing new treatments to combat AMR and prevent its spread.
Roopal Thakkar, M.D., executive vice president of research & development at AbbVie, commented on the collaboration needed to tackle AMR: "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 combines aztreonam with avibactam to counteract multidrug-resistant Gram-negative bacteria. It was supported by findings from the Phase 3 REVISIT study evaluating its efficacy against serious infections caused by these pathogens.
In 2019, EMBLAVEO received Qualified Infectious Disease Product (QIDP) Designation and Fast Track Designation from the FDA. These designations provide incentives like priority review for developing new antibiotics.
AbbVie holds commercialization rights for EMBLAVEO in the U.S. and Canada while Pfizer manages it elsewhere. The medication will be available commercially in the U.S. starting Q3 2025.
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