Fda approves AYCAZ ® for supplementary listing of cUTI and cIAI for treatment of children over 3 months of time

recently, Allergan(http:// announcedthat the U.SFDA http://
has approved itsdrug(http://AVYCAZ ® (ceftazidime-cephalosporine and avibactam) for complex intra-abdominal infections (cUTI) and complex urinary tract infections (cIAI) for more than three monthsAbout AVYCAZ
AVYCAZ is a fixed-dose compound formulation consisting of ceftazidime (cephalosporine) and avibactam, of which avibactam is a world-first (first-in-class) non-beta-class Endamine inhibitors, can protect cephalosporine from the degradation of certain beta-lactamase, will not reduce the activity of cephalosporine to cephalosporine-sensitive bacteria;The AVYCAZ ® specification extension was approved on the basis of clinical studies of two active drug controls that assessed the effectiveness of aYCAZ treatment in children or infants with cUTI or cIAI, and also referred to single-dose pharmacokinetics studiesThe safety and efficacy of aVYCAZ (combined mantinosine) and meroppenan control were compared in the study of the treatment of cIAIIn the study treating cUTI, AVYCAZ was compared with cephalosporine
the main purpose of these studies was to assess the safety and tolerance of AVYCAZ, rather than to statisticallyanalytical analysis of efficacy
(http://The descriptive efficacy analysis in the children's study was consistent with the data from the adult cUTI and cIAI studiesin the children's cIAI study, the clinical cure rate of AVYCAZ and mitanezole group was 91.8% (56/61), the merofennan group was 95.5% (21/22); In the children's cUTI study, the clinical and microbial response rates of AVYCAZ group and cephalosporine group in patients with microbial intent therapy were: 72.2% (39/54) and cephalosporine group 60.9% (14/23) in amicrobial response rate of Ecoli, the most common urinary pathogen in this study, 79.6% in the AVYCAZ group and 59.1% in cephalosporine group128 patients under 3 months of age and under the age of 18 were treated in the(http://of the entiretrialOverall, the results of the children's study were similar to those previously determined to be used in the treatment of cUTI and cIAI adult patients, and no new safety issues were found in children