Allergan : FDA Approves AVYCAZ For Pediatric Patients

(RTTNews) - Allergan plc (AGN) said that the U.S. Food and Drug Administration has approved the company's supplemental New Drug Application or sNDA for AVYCAZ (ceftazidime and avibactam), expanding the label to include pediatric patients 3 months and older for the treatment of complicated intra-abdominal infections (cIAI) in combination with metronidazole and complicated urinary tract infections (cUTI).

This is the first FDA approval of a pediatric indication for cUTI and cIAI in more than a decade.

The label expansion was approved based on results from two active-controlled clinical studies evaluating AVYCAZ in children or infants with cIAI or cUTI, as well as a single-dose pharmacokinetic study. In the cIAI study, the safety and efficacy of AVYCAZ (in combination with metronidazole) was compared with meropenem. In the cUTI study, AVYCAZ was compared with cefepime.

Across the trials, 128 pediatric patients 3 months to less than 18 years of age were treated with AVYCAZ. Overall, the findings from the pediatric studies were similar to the previous determination of safety for AVYCAZ for the treatment of adult patients with cIAI or cUTI, and no new safety concerns were identified in pediatric patients.