FDA Approves AbbVie Treatment for Complicated Intra-Abdominal Infections
These infections can be caused by certain Gram-negative microorganisms, making the infections challenging to control due to high antimicrobial resistance.
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FDA has approved Emblaveo (aztreonam and avibactam), an AbbVie product, as the first fixed-dose, intravenous monobactam/β-lactamase inhibitor combination antibiotic in the United States, to be used in combination with metronidazole in adults with either limited or no other options for treating complicated intra-abdominal infections (cIAI) (1).
In a press release on Feb. 7, 2025, AbbVie identified the Gram-negative microorganisms Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens as potential causes of cIAI, and said that such infections are “among the most challenging” for medical professionals to treat because of their high antimicrobial resistance (AMR) (1).
According to AbbVie, AMR is considered an urgent threat to public health and has been projected to contribute to 39 million worldwide deaths by the year 2050 (1). In 2021 alone, the company said, an estimated 1.14 million deaths were attributed to bacterial AMR. Most troubling, AbbVie said, is that a failure to address AMR now could eventually lead to things like routine surgical procedures or minor infections becoming life-threatening or fatal.
"The continued evolution of antimicrobial resistance among Gram-negative bacteria has left some patients with little to no treatment options, resulting in extended hospital stays, additional morbidity, and death," said James A. McKinnell, MD, infectious disease specialist, Milefchik-Rand Medical Group, Torrance Memorial Medical Center in Torrance, Calif., in the press release. "The approval of Emblaveo provides physicians a much-needed therapeutic option to help address some of the most difficult antimicrobial-resistant pathogens and provides doctors an opportunity to treat patients with these challenging infections."
FDA previously granted both Qualified Infectious Disease Product and Fast Track designations to Emblaveo in 2019 (1). The treatment is slated to be available for commercial use in the US in the third quarter of 2025.
"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," said Roopal Thakkar, MD, executive vice president, research & development, chief scientific officer, AbbVie, in the release. "We're proud to offer this important novel treatment option to urgently address the significant threat of antimicrobial resistance."
AbbVie garnered another FDA approval in October 2024, when its Vyalev (foscarbidopa and foslevodopa) treatment was green-lighted for adult patients with advanced Parkinson’s disease, making it the first subcutaneous, 24-hour infusion of levodopa-based therapy for treatment of motor fluctuations in those patients in the US (2).
The company has also announced numerous acquisitions since the middle of 2024. In June 2024, AbbVie acquired Celsius Therapeutics, which specialized in anti-inflammatory disease therapies, in a $250 million cash deal (3). Following that, the completion of the acquisition of the neuroscience disease-focused clinical-stage biotherapeutics company Cerevel Therapeutics was announced by AbbVie in August 2024 (4).
Another pair of transactions made news in December 2024; first, AbbVie confirmed that its acquisition of Aliada Therapeutics, a biotechnology company centered on central nervous system drug development, had been completed (5). That was followed by the announcement of a definitive agreement for AbbVie to acquire Nimble Therapeutics, another biotech company, this one specializing in oral peptide therapeutics (6).
References
1. AbbVie. U.S. FDA Approves Emblaveo (aztreonam and avibactam) for the Treatment of Adults with Complicated Intra-Abdominal Infections With Limited or No Treatment Options. Press Release. Feb. 7, 2025.
2. AbbVie. U.S. FDA Approves Vyalev (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Disease. Press Release. Oct. 17, 2024.
3. AbbVie. AbbVie Acquires Celsius Therapeutics. Press Release. June 27, 2024.
4. AbbVie. AbbVie Completes Acquisition of Cerevel Therapeutics. Press Release. Aug. 1, 2024.
5. AbbVie. AbbVie Completes Acquisition of Aliada Therapeutics. Press Release. Dec. 11, 2024.
6. AbbVie. AbbVie to Acquire Nimble Therapeutics, Further Strengthening Immunology Pipeline. Press Release. Dec. 13, 2024.
