Avycaz Approval Expanded to Younger Patients With Difficult-to-Treat Infections

The Food and Drug Administration (FDA) has expanded the labeling for Avycaz (ceftazidime and avibactam) to include pediatric patients from birth (at least 31 weeks gestational age) to less than 3 months for the treatment of complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI) including pyelonephritis, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). 

Previously, Avycaz had only been approved for adults and pediatric patients 3 months of age and older. The expanded approval was based on data from an open-label, single-arm, multicenter, phase 2 study (ClinicalTrials.gov Identifier: NCT04126031) that evaluated the pharmacokinetics, safety, and tolerability of Avycaz in 46 pediatric patients from birth (gestational age ≥31 weeks) to less than 3 months; the median age was 24 days. 

The overall safety profile of Avycaz in this pediatric population was similar to that seen in adults with cIAI, cUTI, and HABP/VABP. There was 1 death reported in the trial and no treatment discontinuations due to adverse reactions. The most common adverse reactions (incidence ≥3%) were vomiting and increased transaminases.

In this trial, 25 patients with suspected or confirmed bacterial infection received a single dose of Avycaz, while 21 patients with suspected or confirmed serious gram-negative infections received multiple doses. Among patients who received multiple Avycaz doses, the mean treatment duration was 6 days and the maximum treatment duration was 12 days.

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