Emblaveo FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 9, 2025.
FDA Approved: Yes (First approved February 7, 2025)
Brand name: Emblaveo
Generic name: avibactam and aztreonam
Dosage form: Lyophilized Powder for Injection
Company: AbbVie Inc.
Treatment for: Intraabdominal Infection
Emblaveo (aztreonam and avibactam) is a monobactam antibacterial and beta-lactamase inhibitor combination used for the treatment of complicated intra-abdominal infections.
- Emblaveo when used in combination with metronidazole is indicated in patients 18 years and older 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.
Approval of this indication is based on limited clinical safety and efficacy data for Emblaveo. - Complicated intra-abdominal infections extend beyond the hollow viscus of origin into the peritoneal space and are associated with either abscess formation or peritonitis.
- Emblaveo contains a 3:1 fixed ratio combination of the monobactam antibacterial aztreonam, and the beta-lactamase inhibitor avibactam. Aztreonam, first approved under the brand name Azactam in 1986, works by inhibiting bacterial peptidoglycan cell wall synthesis following binding to penicillin binding proteins, which leads to bacterial cell lysis and death. Avibactam works to protect aztreonam from serine beta-lactamase hydrolysis and restores its activity against bacteria that co-produce metallo-beta-lactamases (a type of enzyme produced by certain bacteria that can become resistant to antibiotics) and serine beta-lactamases.
- FDA approval of Emblaveo was supported by prior findings regarding the efficacy and safety of aztreonam for the treatment of cIAI, and clinical trial results from the Phase 3 REVISIT study.
- Emblaveo is administered by intravenous infusion over 3 hours. A loading dose is followed by maintenance doses every 6-12 hours (based on creatinine clearance) for 5 to 14 days.
- Warnings and precautions associated with Emblaveo include hypersensitivity reactions, epidermal necrolysis in patients undergoing bone marrow transplant with multiple risk factors, elevations in hepatic transaminases, and clostridioides difficile-associated diarrhea.
- Common adverse reactions (incidence >5%) include hepatic adverse reactions, anemia, diarrhea, hypokalemia, and pyrexia.
Development timeline for Emblaveo
Further information
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