Allergan announced that the Food and Drug Administration (FDA) has approved the use of Avycaz (ceftazidime, avibactam) to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) in patients aged ≥18 years caused by the following susceptible Gram-negative microorganisms: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae.

The expanded approval was supported by data from the Phase 3 double-blind REPROVE study (N=870) comparing the safety and efficacy of Avycaz vs meropenem for the treatment of adults with HABP/VABP. The primary efficacy endpoint was 28-day all-cause mortality in the intent-to-treat population. 

Avycaz proved non-inferior to meropenem regarding the primary endpoint (based on a 10% non-inferiority margin) with a 28-day all-cause mortality rate of 9.6% in the Avycaz group vs 8.3% in the meropenem group (treatment difference 1.5%, 95% CI: -2.4, 5.3). The safety profile of Avycaz was similar to that seen in previous trials and with the known safety profile of ceftazidime alone. Diarrhea and vomiting were the most frequent adverse reactions. 

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Avycaz, a combination antibacterial, was initially approved by the FDA in February 2015 for the treatment of adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole. Then in 2017, it was approved for complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Gram-negative bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa

Avibactam is a first-in-class non-beta-lactam beta-lactamase inhibitor which protects ceftazidime, a cephalosporin, against degradation by certain beta-lactamases.

Avycaz is available as 2g/0.5g strength vials in 1- and 10-count cartons. 

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