FDA Approves EMBLAVEO™ for Complex Intra-Abdominal Infections in Adults

AbbVie has announced that the U.S. Food and Drug Administration (FDA) has approved EMBLAVEO™ (a combination of aztreonam and avibactam) as the first and only fixed-dose, intravenous monobactam/β-lactamase inhibitor antibiotic. This new medication is to be used in conjunction with metronidazole for treating complicated intra-abdominal infections in adults aged 18 and above who have limited or no alternative treatment options. This approval is specifically targeted at combating infections caused by susceptible Gram-negative microorganisms such as Escherichia coli and Klebsiella pneumoniae, among others.

The challenge of treating Gram-negative bacterial infections stems from their high resistance to antimicrobial treatments. Antimicrobial resistance (AMR) poses a significant threat to global health, with projections suggesting it could cause over 39 million deaths worldwide by 2050. In 2021, bacterial AMR was linked to around 1.14 million deaths globally.

EMBLAVEO's introduction is a significant development in addressing this threat. James A. McKinnell, M.D., an infectious disease specialist, noted that the emergence of drug resistance among Gram-negative bacteria has left some patients with very few treatment options, thereby leading to prolonged hospital stays and increased mortality. EMBLAVEO provides healthcare professionals with a much-needed option to tackle these difficult-to-treat infections.

The medication combines aztreonam, a monobactam antibiotic, with avibactam, a β-lactamase inhibitor, which together effectively combat bacteria that produce Metallo-β-lactamases (MBLs) and serine β-lactamases. These enzymes contribute to antibiotic resistance, making infections particularly hard to treat. The drug's approval was supported by clinical trials, including the Phase 3 REVISIT study, which examined its efficacy and safety for treating serious Gram-negative bacterial infections.

EMBLAVEO was granted the FDA's Qualified Infectious Disease Product (QIDP) Designation and Fast Track Designation in 2019, which provided certain development incentives, such as priority review. These designations are part of the FDA's efforts to encourage the development of treatments for serious conditions with limited treatment options.

The Phase 3 REVISIT study was a large-scale trial evaluating the safety and effectiveness of EMBLAVEO, enrolling 422 patients globally. The study's primary focus was on achieving a clinical cure at a particular test-of-cure visit among the participants. The outcomes of this study were positive, reinforcing the drug's role as a crucial option for patients with challenging infections.

The drug is set to become available for commercial use in the U.S. by the third quarter of 2025. Its approval in the European Union for broader indications further underscores its global significance in tackling antimicrobial resistance.

The development of EMBLAVEO was a collaborative effort between AbbVie and Pfizer, with AbbVie handling commercialization in the U.S. and Canada, while Pfizer covers other international markets. This development was also supported by partnerships with various health organizations, including the U.S. Department of Health and Human Services and European initiatives focused on combating bacterial resistance.

In conclusion, the approval of EMBLAVEO marks a pivotal moment in the fight against antimicrobial resistance, providing healthcare professionals with an innovative tool to address the rising threat of drug-resistant Gram-negative bacterial infections.