FDA Approves AbbVie’s Emblaveo for Complicated Intra-Abdominal Infections
Emblaveo marks the first and only fixed-dose intravenous monobactam/β-lactamase inhibitor combination antibiotic to be approved by the FDA for complicated intra-abdominal infections with limited treatment options.
Image Credit: Adobe Stock Images/nuanjan
The FDA has approved AbbVie’s Emblaveo (aztreonam and avibactam) for adults with complicated intra-abdominal infections (cIAI) who have limited or no alternative treatment options. The regulatory action marks the first fixed-dose intravenous monobactam/β-lactamase inhibitor combination antibiotic to gain FDA approval.
The approval was supported by limited data from the Phase III REVISIT trial, which demonstrated efficiency against multidrug-resistant pathogens. Used in combination with metronidazole, Emblaveo is active against key Gram-negative pathogens, including multidrug-resistant strains. AbbVie also stated that given the rising threat of antimicrobial resistance (AMR), this approval provides a critical new option for healthcare providers managing difficult-to-treat infections. As a result of the development of AMR, medicines intended to treat cIAI have become ineffective, resulting in an increased risk of mortality and morbidity.1
"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, Torrance, California, in a 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."
The randomized, active-controlled, central assessor-blinded, multicenter REVISIT trial compared Emblaveo and metronidazole versus the combination of meropenem and colistin in patients with cIAI or hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. The study included a total of 422 patients, 312 of whom were hospitalized. Patients were randomly assigned in a 2:1 ratio to receive the Emblaveo combination or meropenem combination from five to 14 days. The primary endpoint of the study was clinical cure at the test-of-cure visit in the intent-to-treat (ITT) population, while secondary endpoints included 28-day mortality and safety in patients in the ITT population who received the treatment.1
Results found that 68.4% of patients in the aztreonam-avibactam group and 65.7% in the meropenem group had clinical cure at the test-of-cure visit (treatment difference 2.7% [95% CI -6.6 to 12.4]). Additionally, the adjudicated clinical cure rate for patients with cIAI was 76.4% in the aztreonam-avibactam group and 74.0% in the meropenem group. Further, 28-day all-cause mortality rates were 4% for aztreonam-avibactam and 7% for meropenem. Patients with cIAI also demonstrated a 2% mortality rate in the aztreonam-avibactam group and 3% in the meropenem group, respectively.2
AbbVie warns that Emblaveo is contraindicated in patients with known hypersensitivity to aztreonam and avibactam. Additionally, adverse events (AEs) included rash, flushing, and bronchospasm. As a result, the company stated that patients should be evaluated for a history of these reactions to aztreonam and avibactam. More common AEs included hepatic AEs, anemia, diarrhea, hypokalemia, and pyrexia. Further, patients undergoing bone marrow transplant have experienced toxic epidermal necrolysis with multiple risk factors including sepsis, radiation therapy, and other concomitantly administered drugs associated with toxic epidermal necrolysis.1
"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, EVP, research & development, chief scientific officer, AbbVie, in the press release. "We're proud to offer this important novel treatment option to urgently address the significant threat of antimicrobial resistance."
Recognized as a Qualified Infectious Disease Product with Fast Track Designation, AbbVie plans for Emblaveo to be commercially available in Q3 of this year.1
References
1. U.S. FDA Approves EMBLAVEO™ (aztreonam and avibactam) for the Treatment of Adults With Complicated Intra-Abdominal Infections With Limited or No Treatment Options. AbbVie. February 7, 2025. Accessed February 11, 2025. https://news.abbvie.com/2025-02-07-U-S-FDA-Approves-EMBLAVEO-TM-aztreonam-and-avibactam-for-the-Treatment-of-Adults-With-Complicated-Intra-Abdominal-Infections-With-Limited-or-No-Treatment-Options
2. Aztreonam-avibactam versus meropenem for the treatment of serious infections caused by Gram-negative bacteria (REVISIT): a descriptive, multinational, open-label, phase 3, randomized trial. PudMed. Accessed February 11, 2025. https://pubmed.ncbi.nlm.nih.gov/39389071/
FDA Approves Supernus Pharmaceuticals’ Onapgo for Managing Motor Fluctuations in Parkinson Disease
February 7th 2025Approval of Onapgo (apomorphine hydrochloride) marks the first and only subcutaneous apomorphine infusion device for managing motor fluctuations in adults with advanced Parkinson disease.
FDA Approves Roche’s Susvimo Refillable Eye Implant for Diabetic Macular Edema
February 4th 2025Roche’s Susvimo, a refillable eye implant for diabetic macular edema, provides continuous delivery of ranibizumab, showing sustained vision improvements with fewer treatments than standard eye injections.
