The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Avycaz (ceftazidime/avibactam; Allergan) to update its labeling with clinical data in the treatment of complicated intra-abdominal infections (cIAI) caused by susceptible microorganisms.
The labeling update included results from a Phase 3 trial evaluating the efficacy and safety of Avycaz, in combination with metronidazole, for the treatment of patients with cIAI. The study met its primary endpoint, demonstrating that treatment with Avycaz with metronidazole showed statistical non-inferiority to meropenem in clinical cure rates at the Test of Cure (TOC) time point. Clinical cure rates for patients treated with Avycaz in a subset of patients with infections due to ceftazidime-resistant pathogens, as well as a subset who had pathogens that produced certain extended-spectrum beta-lactamases (ESBLs), were similar to the overall results.
The FDA approved Avycaz in February 2015 for the treatment of adult patients with cIAI, in combination with metronidazole, and complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa. Allergan has recently completed Phase 3 studies for Avycaz in the treatment of cUTI and currently analyzing the data for submission later this year.
Avycaz is a combination antibiotic consisting of ceftazidime, a third-generation cephalosporin, and avibactam, a non-β lactam β-lactamase inhibitor.
For more information call (800) 433-8871 or visit Allergan.com.