FDA

Emblaveo approved for complicated intra-abdominal infections

February 10, 2025

Brand name: Emblaveo

Generic name: aztreonam and avibactam

Manufacturer: Abbvie

Approval date: February 7, 2025

FDA approved Emblaveo (aztreonam and avibactam) in combination with metronidazole for patients ≥18 years of age who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI), including those caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens.

Efficacy

Approval was based on results from the phase 3 REVISIT trial (NCT03329092) that evaluated Emblaveo +/- metronidazole vs. the combination of meropenem +/- colistin in patients with cIAI or hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (not an approved indication for Emblaveo). The study enrolled 422 patients across 81 locations globally. Primary endpoint was clinical cure at the test-of-cure visit in the intent-to-treat (ITT) population. Secondary endpoints included 28-day mortality in the ITT population, and safety in patients in the ITT population who received the study drug. The trial included 312 hospitalized patients with cIAI who were randomized 2:1 to receive treatment with Emblaveo + metronidazole or meropenem +/- colistin for 5 to 14 days. The adjudicated clinical cure rate was 76.4% in the Emblaveo + metronidazole group and 74.0% in the meropenem +/- colistin group. All-cause mortality rates were 2% and 3%, respectively.

Safety

The most common adverse reactions (incidence >5%) were hepatic adverse reactions, anemia, diarrhea, hypokalemia, and pyrexia.

Sources:

US FDA approves Emblaveo™ (aztreonam and avibactam) for the treatment of adults with complicated intra-abdominal infections with limited or no treatment options. Abbvie. 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

Carmeli Y, et al; COMBACTE-CARE consortium REVISIT study group. Lancet Infect Dis. Aztreonam-avibactam versus meropenem for the treatment of serious infections caused by Gram-negative bacteria (REVISIT): a descriptive, multinational, open-label, phase 3, randomised trial. https://pubmed.ncbi.nlm.nih.gov/39389071/

Emblaveo. Package insert. Abbvie. 2025. https://www.rxabbvie.com/pdf/emblaveo_pi.pdf