FDA Approves AbbVie’s Emblaveo for Complicated Intra-Abdominal Infections

The FDA has approved AbbVie's Emblaveo (aztreonam and avibactam) for treating complicated intra-abdominal infections (cIAI) in adults with limited or no alternative treatment options136.

Emblaveo is the first and only fixed-dose, intravenous monobactam/β-lactamase inhibitor combination antibiotic approved by the FDA6.

It is designed to treat infections caused by Gram-negative bacteria that are resistant to common antibiotics, including Escherichia coli and Klebsiella pneumoniae13.

Emblaveo is to be used in combination with metronidazole for patients 18 years and older16.

The approval was based on clinical trial results, including the Phase 3 REVISIT study, which showed similar cure rates between Emblaveo and meropenem for cIAI (76.4% vs 74%)36.

Common side effects include liver problems, anemia, diarrhea, low potassium levels, and fever3.

Emblaveo is expected to be available in the U.S. by late 2025 or in the third quarter of 202539.

The FDA granted Qualified Infectious Disease Product (QIDP) Designation and Fast Track Designation for Emblaveo in 20196.

Antimicrobial resistance (AMR) is a growing global health threat, with an estimated 1.14 million deaths attributed to bacterial AMR in 2021 alone6.

Emblaveo was jointly developed with Pfizer, with AbbVie holding commercialization rights in the U.S. and Canada9.

Sources:

1. https://www.pharmaceutical-technology.com/news/fda-abbvie-emblaveo-intra-abdominal-infections/

3. https://www.webmd.com/digestive-disorders/news/20250210/fda-oks-new-antibiotic-combo-abdominal-infections

6. https://www.prnewswire.com/news-releases/us-fda-approves-emblaveo-aztreonam-and-avibactam-for-the-treatment-of-adults-with-complicated-intra-abdominal-infections-with-limited-or-no-treatment-options-302371478.html

9. https://www.managedhealthcareexecutive.com/view/fda-approves-combination-antibiotic-for-complicated-infections