FDA: Priority Review Granted to Expand Indications for Ceftazidime/Avibactam
Avycaz proved non-inferior to meropenem regarding 28-day all-cause mortality in the intent-to-treat population.
Allergan announced that the Food and Drug Administration (FDA) has accepted and granted Priority Review for a supplemental New Drug Application (sNDA) for Avycaz (ceftazidime/avibactam). The sNDA filing seeks to expand the current indications of Avycaz to include hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) in adults.
Avycaz is a combination antibiotic consisting of ceftazidime, a cephalosporin, and avibactam, a beta-lactamase inhibitor. It is currently approved for the treatment of adult patients with complicated intra-abdominal infection (cIAI) in combination with metronidazole and complicated urinary tract infections (cUTI) including pyelonephritis.
The sNDA submission was based on data from the multicenter, randomized, double-blind Phase 3 REPROVE study, which evaluated the efficacy and safety of Avycaz for the treatment of patients with HABP/VABP. In the study, Avycaz proved non-inferior to meropenem regarding 28-day all-cause mortality in the intent-to-treat (ITT) population, the primary endpoint. Avycaz was also non-inferior to meropenem regarding the secondary endpoint, which was clinical cure at the test of cure (TOC) visit in the ITT population. The overall safety of Avycaz in the study was consistent with the current product labeling.
Avycaz is available as 2g/0.5g strength vials in 1- and 10-count cartons.
AVYCAZ [package insert]. Dublin, Republic of Ireland: Allergan, 2015.