Dublin-headquartered Allergan has announced the US Food and Drug Administration (FDA) has approved its supplemental new drug application for Avycaz (ceftazidime and avibactam).
Thereby expanding the drug’s label to include treating paediatric patients with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
The company claims this is the first FDA approval for children with cIAI and cUTI in decades; the drug will now be available for patients over three months old. For cIAI, Avycaz is combined with metronidazole, whereas it is approved alone for cIAI.
Avycaz’s label expansion was based upon results from two active-controlled trials evaluating its safety and one pharmacokinetic study. The drug had similar safety results to trials into adult patients and there were no safety concerns.
The studies did not statistically analyse the clinical efficacy of the drug in paediatric patients, but the descriptive analysis of efficacy was consistent with the results of adult studies.
Allergan chief research and development officer David Nicholson said: “Difficult-to-treat gram-negative pathogens pose a significant health risk, particularly to the vulnerable and sensitive paediatric patient population with few options for treatment.
“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 paediatric 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.”
Avibactam, one of the active pharmaceutical ingredients (APIs) of Avycaz, is an antibacterial non-beta-lactam beta-lactamase inhibitor, which protect the other API ceftazidime against degradation by certain beta-lactamases.
Avycaz, which is being jointly developed with Pfizer, but Allergan holds commercial rights in North America for the combination therapy, was first approved by the FDA in February 2015 for the treatment of cUTI and CIAI. It was then approved in February 2018 for the treatment of adults with hospital-acquired pneumonia and ventilator-associated pneumonia.