The Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Avycaz (ceftazidime and avibactam; Allergen), for the addition of new Phase 3 data to the label.
The sNDA includes results from a trial which evaluated the efficacy and safety of Avycaz in treating patients with complicated urinary tract infections (cUTI), including pyelonephritis, due to designated susceptible pathogens to the current product label. Results indicated that Avycaz was non-inferior to doripenem in both co-primary endpoints (patient-reported symptomatic response at Day 5 and the combined patient-reported symptomatic response and microbiological eradication at the Test of Cure [TOC] visit) in the microbiologically modified intent-to treat (mMITT) population.
The application also included data from a second open-label Phase 3 study comparing AVYCAZ to best available therapy for treating patients with cUTI due to ceftazidime-nonsusceptible (CAZ-NS) pathogens.The results of this study were consistent with the pivotal Phase 3 study evaluating the efficacy and safety of Avycaz for the treatment of patients with cUTI.
Avycaz was first approved in the U.S. in 2015 for the treatment of complicated intra-abdominal infections (cIAI) in combination with metronidazole, and cUTI, including pyelonephritis, caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa.
The FDA is expected to take action on the sNDA in the first quarter of 2017.
For more information visit Avycaz.com.