FDA approves Avycaz (ceftazidime-avibactam) to treat cIAI and cUTI - Actavis

Actavis plc announced the FDA has approved Avycaz (ceftazidime-avibactam). Avycaz was approved for the treatment of adult patients with complicated intra-abdominal infections (cIAI) (in combination with metronidazole) and complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa. Avycaz received a priority review based on Phase II data from the company's clinical development program and supporting in vitro data, and as such should be reserved for use in patients who have limited or no alternative treatment options.

Avycaz combines ceftazidime, a cephalosporin with in vitro activity against certain Gram-negative and Gram-positive bacteria, and avibactam, a non-beta-lactam beta-lactamase inhibitor that inactivates certain key beta-lactamases and protects ceftazidime from degradation by these beta-lactamases. The addition of avibactam to ceftazidime protects ceftazidime from breakdown by Extended Spectrum Beta-Lactamases (ESBL), Klebsiella pneumoniae carbapenemase (KPC) and AmpC producing pathogens.

Comment; The determination of efficacy of Avycaz was supported in part by the findings of the efficacy and safety of ceftazidime for the treatment of cIAI and cUTI. The contribution of avibactam to Avycaz was based on data from in vitro studies and animal models of infection. Avycaz was studied in two Phase II trials, one each in cIAI and cUTI. Both trials were not designed with any formal hypotheses for inferential testing against the active comparators.