AVYCAZ (ceftazidime and avibactam) sNDA filed for patients with complicated urinary tract infections including pyelonephritis- Allergan

Allergan announced the FDA has accepted for filing the company's supplemental New Drug Application (sNDA) for AVYCAZ (ceftazidime and avibactam), seeking the addition of new Phase III clinical trial data evaluating AVYCAZ in patients with complicated urinary tract infections (cUTI), including pyelonephritis, due to designated susceptible pathogens to the current product label. The FDA granted priority review status to this application based on the previous Qualified Infectious Disease Product (QIDP) designation for AVYCAZ and is expected to take action on the filing in the first quarter of 2017.

The application included results from a Phase III study evaluating the efficacy and safety of AVYCAZ for the treatment of patients with cUTI, including pyelonephritis. In this study, AVYCAZ demonstrated non-inferiority to doripenem with regard to 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. In a subset of patients with cUTI due to CAZ-NS pathogens, as well as a subset who had pathogens that produced certain ESBLs, clinical cure rates for patients treated with AVYCAZ were similar to the overall results. The application also included data from a second open-label Phase III study comparing AVYCAZ to best available therapy for treating patients with cUTI due to CAZ-NS pathogens. The results of this study were consistent with the pivotal Phase III study evaluating the efficacy and safety of AVYCAZ for the treatment of patients with cUTI.

Comment: AVYCAZ was first approved in the U.S. in February 2015 for the treatment of adult patients with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and cUTI, including pyelonephritis, caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa. In June 2016, the FDA approved the addition of data from a Phase III cIAI clinical trial to the label that evaluated the safety and efficacy of AVYCAZ, in combination with metronidazole, for the treatment of cIAI including data from a subset of patients with infections caused by ceftazidime-nonsusceptible (CAZ-NS) pathogens and a subset of patients with pathogens producing certain extended-spectrum beta-lactamases (ESBLs).