FDA Approves AbbVie & Pfizer’s Emblaveo for cIAI Amid Rising AMR Concerns
AbbVie has announced that the U.S. Food and Drug Administration (FDA) has approved Emblaveo (aztreonam-avibactam)—a novel antibiotic therapy developed in partnership with Pfizer—to treat complicated intra-abdominal infections (cIAI), including those caused by multidrug-resistant Gram-negative bacteria.
This approval makes Emblaveo the first and only monobactam/beta-lactamase inhibitor combination therapy authorized for this indication, marking a significant advancement in antimicrobial resistance (AMR) treatment.
A Critical Step in the Fight Against AMR
AMR—a top ten global health threat, according to the World Health Organization (WHO)—is a pressing health-related concern that leads to increased morbidity & mortality. The emergence of multidrug-resistant Gram-negative bacteria poses a particular challenge due to their ability to evade existing treatments. Hence, Pfizer’s Emblaveo—an intravenous therapy with limited/ no alternative treatment options for cIAI—is authorized for use in combination with metronidazole, an antibiotic and antiprotozoal agent.
Mechanism of Action and Clinical Efficacy
Emblaveo is a fixed-dose combination of aztreonam (a monobactam antibiotic) that inhibits bacterial cell wall synthesis, leading to bacterial death, and avibactam (a beta-lactamase inhibitor) that prevents bacterial resistance by blocking enzymes that degrade beta-lactam antibiotics, allowing aztreonam to remain effective.
The Phase 3 REVISIT study supported the FDA approval, which demonstrated the therapy’s efficacy, safety, and tolerability in treating adverse infections by Gram-negative bacteria, including those caused by Metallo-beta-lactamase-producing multidrug-resistant pathogens.
AbbVie plans to launch Emblaveo in the U.S. in Q3 2025, while Pfizer will handle commercialization in markets outside the U.S. and Canada.
IeB Perspective
AbbVie’s foray into antimicrobial resistance (AMR) therapies signals a strategic diversification beyond its core focus on immunology and oncology. Its partnership with Pfizer reflects an efficient risk-sharing model, leveraging Pfizer’s global expertise in infectious diseases while maintaining commercial rights in the U.S. and Canada.
Looking ahead, AbbVie may expand its AMR portfolio by forging alliances with biotech firms developing novel antimicrobials, microbiome-based therapies, phage therapy solutions, or next-generation combination antibiotics. Given the growing global focus on combating AMR, such strategic collaborations could enhance AbbVie’s presence in the anti-infectives market while addressing an urgent public health challenge.