FDA OKs New Antibiotic Combo for Complicated Intra-Abdominal Infections

The FDA has approved aztreonam and avibactam (Emblaveo) in combination with metronidazole for adults who have limited or no alternative options for the treatment of complicated intra-abdominal infections, AbbVie announced Friday.

Such infections include those caused by Gram-negative bacteria, such as Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens.

According to the company, the product is the first and only fixed-dose, intravenous, monobactam/beta-lactamase inhibitor combination antibiotic to receive FDA approval.

“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, of Torrance Memorial Medical Center in California, in the announcement. “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.”

Approval was based on the phase III REVISIT trial, the results of which were published recently in Lancet Infectious Diseases.

This randomized, open-label trial evaluated aztreonam-avibactam plus metronidazole versus meropenem with or without colistin in patients with complicated intra-abdominal infections, or hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.

Between April 2018 and February 2023, 422 patients were enrolled and randomly allocated — 282 in the aztreonam-avibactam group and 140 in the meropenem group. Of the patients in the aztreonam-avibactam group, 68.4% had clinical cure at the test-of-cure visit compared with 65.7% of those in the meropenem group.

For patients with complicated intra-abdominal infection, the adjudicated clinical cure rate was 76.4% for the aztreonam-avibactam group and 74% for the meropenem group.

In addition, 28-day all-cause mortality rates were 4% with aztreonam-avibactam and 7% with meropenem, while mortality rates for patients with complicated intra-abdominal infection were 2% and 3%, respectively.

There were no treatment-related serious adverse events in the aztreonam-avibactam group.

AbbVie said the most common adverse reactions occurring at an incidence of greater than 5% include hepatic adverse reactions, anemia, diarrhea, hypokalemia, and pyrexia.

Please enable JavaScript to view the

comments powered by Disqus.