AbbVie’s Emblaveo approved for cIAI in patients with limited treatment options

USA—AbbVie has announced that the U.S. Food and Drug Administration (FDA) has approved Emblaveo—a combination of aztreonam and avibactam—for the treatment of complicated intra-abdominal infections (cIAI) in adults aged 18 and over.

This approval is specifically for patients who have limited or no alternative treatment options. Emblaveo is to be administered alongside the antibiotic metronidazole.

This approval is significant as Emblaveo becomes the first and only intravenous fixed-dose combination of a monobactam antibiotic and a β-lactamase inhibitor.

The therapy targets cIAI caused by Gram-negative bacteria, including Escherichia coli and Klebsiella pneumoniae.

The combination works by pairing aztreonam, a monobactam antibiotic, with avibactam, a β-lactamase inhibitor that protects against serine β-lactamase hydrolysis.

This pairing restores the antibiotic’s effectiveness against bacteria that produce metallo-β-lactamases (MBLs), enzymes that often render other antibiotics ineffective.

Previous studies demonstrating aztreonam’s safety and efficacy in treating cIAI supported the FDA’s decision.

Additionally, results from the Phase III REVISIT trial played a crucial role in the approval process.

This trial evaluated the therapy’s tolerability, efficacy, and safety against serious Gram-negative bacterial infections, including those resistant to multiple drugs.

Roopal Thakkar, AbbVie’s Executive Vice President of Research and Development and Chief Scientific Officer, emphasized the importance of collaboration in combating evolving bacterial threats.

“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, ” Thakkar.

“We’re proud to offer this important novel treatment option to urgently address the significant threat of antimicrobial resistance,” he stated.

The FDA had previously granted Emblaveo fast-track status and designated it a qualified infectious disease product (QIDP) in 2019, recognizing the urgent need for new treatments in this area.

 The drug is expected to be commercially available in the U.S. by the third quarter of 2025.

AbbVie holds the commercialization rights for Emblaveo in the U.S. and Canada, while Pfizer is responsible for its availability in other regions.

The development of Emblaveo was a collaborative effort between AbbVie and Pfizer.

It also benefited from public-private partnerships, including support from the U.S. Department of Health and Human Services, the Administration for Strategic Preparedness and Response, the Biomedical Advanced Research and Development Authority (BARDA), and the European Union’s Innovative Medicines Initiative (IMI) under the COMBACTE-CARE project.

The COMBACTE pan-European clinical and laboratory networks support this consortium.

In a related development, in October 2024, the FDA approved AbbVie’s Vyalev for treating motor fluctuations in adults with advanced Parkinson’s disease, further showcasing the company’s commitment to addressing unmet medical needs.

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