The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA), expanding the label for ceftazidime and avibactam (AVYCAZ) to include pediatric patients 3 months and older for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) in combination with metronidazole.
“Difficult-to-treat gram-negative pathogens pose a significant health risk, particularly to the vulnerable and sensitive pediatric patient population with few options for treatment,” David Nicholson, PhD, chief research & development officer at Allergan said in a statement, further indicating that this marks the first approval of an indication for cUTI and cIAI in pediatric patients in more than a decade.
Ceftazidime/avibactam is a fixed-dose combination antibacterial. Avibactam is a non-beta-lactam beta-lactamase inhibitor, which protects ceftazidime from degradation by some beta-lactamases. Avibactam does not decrease the activity of ceftazidime against ceftazidime-susceptible organisms. Ceftazidime is a third-generation cephalosporin with a well-established efficacy and safety profile.
According to Allergan, which holds commercialization rights to ceftazidime and avibactam, the label expansion was based upon results from 2 active, controlled studies and 1 single-dose pharmacokinetic study that evaluated ceftazidime and avibactam in infants and children. In the cIAI study, ceftazidime/avibactam was compared to meropenem and in the cUTI study the drug was compared to cefepime.
The studies evaluated a total of 128 pediatric patients between 3 months and 18 years and did not observe any new safety concerns. According to the results of the efficacy analyses, the pediatric studies were consistent with data from the studies in adults.