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FDA Approves Label Expansion for Ceftazidime and Avibactam to Include Pediatric Patients

MAR 18, 2019 | MICHAELA FLEMING
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.

In the pediatric cIAI study, the clinical cure rate at the test-of-cure visit was 91.8% in the ceftazidime and avibactam + metronidazole group and 95.5% in the meropenem group. Clinical cure rates for the predominant pathogens, Escherichia coli and Pseudomonas aeruginosa, were 90.5% and 85.7%, respectively, for patients treated with ceftazidime and avibactam + metronidazole, and 92.3% and 88.9%, respectively, for patients treated with meropenem.

In the pediatric cUTI study, the combined favorable clinical and microbiological response rate at test-of-cure visit was 72.2% in the ceftazidime and avibactam group and 60.9% in the cefepime group. The microbiologic response rate for E coli was 79.6% for patients treated with ceftazidime and avibactam and 59.1% for patients treated with cefepime.

The most common adverse events in pediatric patients were vomiting, diarrhea, rash, and infusion site phlebitis.

Ceftazidime and avibactam was first approved by the FDA in February 2015 for the treatment of cUTI including pyelonephritis, and cIAI in combination with metronidazole, caused by designated susceptible bacteria including certain Enterobacteriaceae and P aeruginosa, for patients 18 years of age and older.

Ceftazidime and avibactam was approved for the treatment of hospital-acquired pneumonia / ventilator-associated pneumonia in adults over 18 caused by K pneumoniae, E cloacae , E coli, Serratia marcescens, Proteus mirabilis, P aeruginosa, and Haemophilus influenzae in February of 2018.

Ceftazidime and avibactam is being jointly developed with Pfizer. Allergan holds the rights to commercialize ceftazidime and avibactam in North America, while Pfizer holds the rights to commercialize the combination in the rest of the world.
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