Allergan announced that the Food and Drug Administration (FDA) has expanded the approval of Avycaz (ceftazidime and avibactam) to include pediatric patients aged ≥3 months for the treatment of complicated intra-abdominal infections (cIAI), used in combination with metronidazole, and for complicated urinary tract infections (cUTI), including pyelonephritis.

The approval was supported by data from 2 active-controlled studies evaluating Avycaz in children or infants with cIAI (vs meropenem) and cUTI (vs cefepime), and a single-dose pharmacokinetic study; a total of 128 patients (3 months to <18 years old) were treated with Avycaz.

In the cIAI study, the clinical cure rate at the test-of-cure (TOC) visit in the intent-to-treat (ITT) population was 91.8% in the Avycaz + metronidazole group vs 95.5% in the meropenem group. In the cUTI study, the combined clinical and microbiological response rate at TOC in the microbiological-ITT population was 72.2% in the Avycaz group vs 60.9% in the cefepime group.

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Overall, the safety profile for Avycaz was found to be similar in the pediatric and adult trials; no new safety issues were observed in the pediatric population.

Avycaz is supplied as 2g/0.5g strength powder for IV injection in single-use vials.

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