Allergan announced that the Food and Drug Administration (FDA) has approved an update to the Avycaz (ceftazidime and avibactam) label to include Phase 3 clinical data supporting the treatment of patients with complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Gram-negative microorganisms. Infections from resistant Gram-negative bacteria have been increasing in recent years prompting the Centers for Disease Control and Prevention (CDC) to classify these pathogens as a serious public health threat.
The expanded approval was based on data from 2 Phase 3 trials, RECAPTURE (n=1020) and REPRISE (n=305). In RECAPTURE, Avycaz proved non-inferior to doripenem with regard to both primary endpoints in the microbiologically modified intent-to-treat (mMITT) population. The symptomatic response rate at Day 5 in the Avycaz-treated patients was 70.2% vs 66.2% in doripenem-treated patients. The combined symptomatic and microbiological response rate at Test of Cure (TOC) in the Avycaz-treated patients was 71.2% vs 64.5% in doripenem-treated patients.
In REPRISE, Avycaz showed a higher combined clinical and microbiological cure rate vs best available therapy, including meropenem, imipenem, doripenem, and colistin. The combined clinical and microbiological cure rate at Days 21-25 in the mMITT population was higher in Avycaz-treated patients than in patients on best available therapy (BAT). The combined cure rates were 70.1% for Avycaz-treated patients and 54% for BAT-treated patients.
Both trials included a subset of patients with infections caused by pathogens producing certain extended spectrum beta-lactamase groups and AmpC beta-lactamases in which the clinical and microbiological cure rates were similar to the overall results.
Avycaz, a cephalosporin and beta-lactamase inhibitor antibiotic, was approved in February 2015 to treat susceptible infections including complicated intra-abdominal infections (cIAI), in combination with metronidazole, and cUTI, including pyelonephritis. In June 2016, the FDA approved the addition of Phase 3 cIAI data to the label that evaluated the safety and efficacy of Avycaz, in combination with metronidazole in cIAI patients, including subsets of patients with infections caused by ceftazidime non-susceptible pathogens and pathogens producing certain ESBLs.
Avycaz is available a 2g/0.5g strength powder for IV injection in 1 and 10 single-use vials.
For more information call or visit Avycaz.com.
Avycaz [package insert]. Parsippany, NJ: Allergan, Inc.; 2017.
This article originally appeared on MPR