New Antibiotic Available for Serious Infections

Avycaz (ceftazidime-avibactam; Actavis) has been made available for the treatment of adult patients with complicated intra-abdominal infections (cIAI) (in combination with metronidazole) and complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa.

Avycaz consists of ceftazidime, a cephalosporin, and avibactam, a non-beta-lactam beta-lactamase inhibitor. The addition of avibactam to ceftazidime protects ceftazidime from breakdown by Extended Spectrum Beta-Lactamases (ESBL), Klebsiella pneumoniae carbapenemase (KPC) and AmpC producing pathogens.

Because clinical safety and efficacy data is limited, Avycaz should be reserved for patients who have limited or no alternative treatment options. The Food and Drug Administration (FDA) approval was supported in part by efficacy and safety data of ceftazidime for the treatment of cIAI and cUTI. In addition, the contribution of avibactam was primarily established via in vitro data and animal models of infection. Avycaz was studied in two Phase 2 trials, one each in cIAI and cUTI, including pyelonephritis. These studies were not designed with any formal hypotheses for inferential testing against the active comparators. Phase 3 studies including studies evaluating Avycaz for the treatment of cIAI and cUTI are underway and targeted for completion in late 2015.

Avycaz for injection is supplied in single-use, clear glass vials for reconstitution. It is available to hospitals for purchase in cartons of ten 2.5g vials.

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