Healthcare company Allergan plc (NYSE:AGN) revealed on Monday the receipt of the US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for AVYCAZ for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI) in paediatric patients.

The company said the US Food and Drug Administration's (FDA) approved its supplemental New Drug Application (sNDA) for AVYCAZ (ceftazidime and avibactam), expanding the label to include paediatric patients three months and older for the treatment of complicated intra-abdominal infections (cIAI) in combination with metronidazole and complicated urinary tract infections (cUTI). AVYCAZ is a fixed-dose combination antibacterial indicated for the treatment of cIAI and cUTI.

This label expansion was approved based on results from the company's 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 company's trials, 128 paediatric patients three months to less than 18 years of age were treated with AVYCAZ. The findings from the paediatric studies were similar to the prior determination of safety for AVYCAZ for treating adult patients with cIAI or cUTI and no new safety concerns were identified in paediatric patients.

Under the company's paediatric cIAI study, the clinical cure rate at the test-of-cure (TOC) visit in the intent-to-treat (ITT) population was 91.8% in the AVYCAZ plus metronidazole group and 95.5% in the meropenem group. In the paediatric cUTI study, the combined favourable clinical and microbiological response rate at TOC in the microbiological-ITT population was 72.2% in the AVYCAZ group and 60.9% in the cefepime group.