Antibiotic combo for paediatric cUTI and cIAIMay 8, 2019
Ceftazidime and avibactam (Avycaz) combination drug got expanded label indication to include paediatric patients 3 months and older for the treatment of complicated intra-abdominal infections (cIAI) in combination with metronidazole and complicated urinary tract infections (cUTI) in US.
This is the first FDA approval of a paediatric indication for cUTI and cIAI in more than a decade, Allergen said in a statement.
The label expansion was approved based on results from two active-controlled clinical studies evaluating ceftazidime and avibactam in children or infants with cIAI or cUTI, as well as a single-dose pharmacokinetic study. In the cIAI study, the safety and efficacy of ceftazidime and avibactam (in combination with metronidazole) was compared with meropenem. In the cUTI study, the combo was compared with cefepime.
In the paediatric cIAI study, the clinical cure rate at the test-of-cure visit in the intent-to-treat population was 91.8% in the ceftazidime and avibactam plus 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 plus metronidazole, and 92.3% and 88.9%, respectively, for patients treated with meropenem.
In the paediatric cUTI study, the combined favourable clinical and microbiological response rate at test-of-cure in the microbiological-ITT population was 72.2% in the ceftazidime and avibactam group and 60.9% in the cefepime group.