Allergan has expanded the label of Avycaz, as it got approval from the US FDA for its supplemental New Drug Application (sNDA), for treating young patients with complicated intra-abdominal infections.
Allergan will now have Avycaz (ceftazidime and avibactam) label expanded 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). Allergan noted that this is the first FDA approval of a pediatric indication for cUTI and cIAI in more than a decade.
“Difficult-to-treat gram-negative pathogens pose a significant health risk, particularly to the vulnerable and sensitive pediatric patient population with few options for treatment,” said David Nicholson, Chief Research & Development Officer at Allergan. “As resistance rises among the gram-negative pathogens that cause these serious infections, the expanded label for AVYCAZ provides a safe and effective treatment option now for pediatric patients with cIAI and cUTI. These expanded indications in pediatric patients with infections, including infants and those at a particularly young age, address an unmet need among this vulnerable population and underscore Allergan’s efforts in anti-infective research.”
The company said in the press release that 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, Avycaz in combination with metronidazole was compared with meropenem. In the cUTI study, it was compared with cefepime.