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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 two Phase 3 trials, RECAPTURE (n=1,020) 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.
