Allergan plc announced the U.S. Food and Drug Administration has approved the company's supplemental New Drug Application to update the label for AVYCAZ (ceftazidime and avibactam) with clinical data from two Phase 3 trials supporting the indication to treat patients with complicated urinary tract infections, including pyelonephritis, caused by designated susceptible Gram-negative microorganisms. In Trial 1, known as RECAPTURE, AVYCAZ was non-inferior to doripenem with regard to both primary endpoints. In Trial 2, known as REPRISE, AVYCAZ demonstrated a higher combined clinical and microbiological cure rate vs. best available therapy, including meropenem, imipenem, doripenem, and colistin. Additionally, both trials included a subset of patients with infections caused by pathogens producing certain ESBL groups and AmpC beta-lactamases in which the clinical and microbiological cure rates were similar to the overall results. The prevalence of infections caused by resistant Gram-negative bacteria, specifically extended spectrum beta-lactamase and Klebsiella pneumoniae carbapenamase -producing carbapenem-resistant Enterobacteriaceae, and resistant Pseudomonasaeruginosa have steadily increased in recent years; this has led the U.S. Centers for Disease Control and Prevention to classify these pathogens as urgent and serious public health threats, as there are very limited treatment options.