Allergan expands label for Avycaz, for intra-abdominal infectionsMarch 19, 2019
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.