The U.S. Food and Drug Administration (FDA) has granted approval for a novel combination antibiotic, Emblaveo. This unique formulation, combining aztreonam and avibactam, is the first-of-its-kind monobactam/β-lactamase inhibitor mix. Set to be commercially available by the third quarter of 2025, this antibiotic solution aims to provide a therapeutic option for patients who have limited or no other avenues for treatment. Infections associated with Gram-negative pathogens such as Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens can be treated with Emblaveo, particularly complicated intra-abdominal infections (cIAI) in patients aged 18 years and above.
The approval of Emblaveo is underpinned by the efficacy and safety of aztreonam, demonstrated in previous studies concerning the treatment of cIAI. Additionally, the phase 3 REVISIT clinical trial results bolstered this approval. This trial was designed to evaluate the efficacy, safety, and tolerability of the aztreonam and avibactam combination in treating dangerous infections induced by Gram-negative bacteria, specifically those caused by MBL-producing multidrug-resistant pathogens lacking sufficient treatment options.
As explained by Dr. James A. McKinnell, a specialist in infectious diseases at Milefchik-Rand Medical Group, Torrance Memorial Medical Center, antimicrobial resistance in Gram-negative bacteria has rendered some patients with perilously few treatment choices, leading at times to longer hospital stays and escalated health risks. Emblaveo’s approval offers a refreshing therapeutic recourse for physicians dealing with these formidable antimicrobial-resistant pathogens.
The drug’s journey to approval was not easy. It underwent rigorous testing in an active-controlled, central assessor-blinded multicenter trial comparing Emblaveo ± metronidazole to a combination of meropenem ± colistin. The study, involving around 422 participants across 81 locations, sought to ascertain clinical cure rates through test-of-cure visits. Secondary measures included 28-day mortality and safety in the intent-to-treat (ITT) population who received the study drug. This trial included 312 hospitalized cIAI patients, who were assigned treatment options with a 2:1 ratio favoring Emblaveo with metronidazole or meropenem ± colistin.
Emblaveo was honored with the Qualified Infectious Disease Product (QIDP) Designation and Fast Track Designation by the FDA in 2019. These distinctions come with developmental incentives and priority review besides being expedited for FDA’s Fast Track Designation and facilitating the review of drugs for serious conditions lacking adequate treatment options with a five-year regulatory exclusivity extension.
Emblaveo’s innovative formula features a powerful blend of aztreonam, a monobactam antibiotic, and avibactam, a β-lactamase inhibitor. The latter safeguards aztreonam from serine β-lactamase hydrolysis and invigorates its action against bacteria producing Metallo-β-lactamases (MBLs) and serine β-lactamases.
In the eyes of Dr. Roopal Thakkar, executive vice president, research & development, chief scientific officer, AbbVie, the advent of Emblaveo is a testament to their commitment to offering advancement in the treatment of antimicrobial resistance. As bacteria continue to evolve, healthcare stakeholders must remain united to ensure that infection prevention experts are well-equipped with tools to combat the mounting threats of antimicrobial resistance.