FDA Approves AbbVie's Emblaveo for Abdominal Infections

AbbVie has achieved a significant milestone with the approval of Emblaveo by the US Food and Drug Administration (FDA). This new medication is designed to treat adults suffering from complicated intra-abdominal infections (cIAI), particularly when traditional treatment options are limited. The therapy is intended for patients aged 18 and over and is used in combination with metronidazole. This approval places Emblaveo as the first intravenous fixed-dose combination of a monobactam and β-lactamase inhibitor, marking an important advancement in antibiotic treatments.

Emblaveo is specifically effective against cIAI caused by Gram-negative bacteria, such as Escherichia coli and Klebsiella pneumoniae. It combines aztreonam, a monobactam antibiotic, with avibactam, a β-lactamase inhibitor. This combination is designed to combat serine β-lactamase hydrolysis and reinstate the antibiotic activity against bacteria that produce Metallo-β-lactamases (MBLs), which are often resistant to common treatments.

The FDA's approval of Emblaveo was underpinned by previous positive data demonstrating the safety and efficacy of aztreonam in treating cIAI. Additionally, data from the Phase III clinical trial, known as REVISIT, played a crucial role. This trial evaluated the tolerance, effectiveness, and safety of the therapy against severe Gram-negative bacterial infections, including those that are multi-drug resistant.

Roopal Thakkar, AbbVie's executive vice-president of research and development and chief scientific officer, emphasized the importance of collaborative efforts in addressing the evolving challenges posed by bacterial infections. Thakkar highlighted the significant threat of antimicrobial resistance and expressed pride in offering a novel treatment option to combat this issue. The approval of Emblaveo underscores the need for cooperation among industry, government, and clinical experts to enhance public health.

The therapy was granted fast track status and the qualified infectious disease product (QIDP) designation by the US regulator in 2019, reflecting its potential to address unmet medical needs. The commercial launch of Emblaveo in the United States is anticipated in the third quarter of this year.

The development of Emblaveo was a joint effort between AbbVie and Pfizer. AbbVie holds the commercialization rights in the United States and Canada, while Pfizer manages the distribution in other global regions. The success of this therapy was further supported by public-private partnerships, including contributions from the US Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority (BARDA). Additionally, the EU’s Innovative Medicines Initiative (IMI) and the COMBACTE-CARE project provided essential backing. This collaboration was made possible through the extensive COMBACTE pan-European clinical and laboratory networks.

In sum, the approval of Emblaveo represents a collaborative achievement in the fight against complex bacterial infections. It offers a new hope for patients with limited treatment options and embodies the spirit of innovation and partnership essential for advancing public health.