FDA approves sNDA for AVYCAZ (ceftazidime and avibactam) in complicated urinary tract infections (cUTI), including pyelonephritis- Allergan

Allergan announced the FDA has approved the company's supplemental New Drug Application (sNDA) to update the label for AVYCAZ (ceftazidime and avibactam) with clinical data from two Phase III trials supporting the indication to treat patients with complicated urinary tract infections (cUTI), 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 (BAT), 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.