FDA approves pediatric indication for Allergan’s Avycaz
The Food and Drug Administration has cleared Allergan’s Avycaz (ceftazidime and avibactam) to include an indication for pediatric patients age 3 months old and older for the treatment of complicated intra-abdominal infections, or cIAI, in combination with metronidazole and complicated urinary tract infections, or cUTI.
This is the first FDA approval of a pediatric indication for cUTI and cIAI in more than a decade, the company said.
"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,"Allergan chief research and development officer David Nicholson said. "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."
Avycaz was first approved by the FDA in February 2015 for the treatment of cUTI, including pyelonephritis, and cIAI in combination with metronidazole caused by designated susceptible bacteria, including certain Enterobacteriaceae and P. aeruginosa, for patients age 18 years old and older. Avycaz was subsequently approved for the treatment of adults with hospital-acquired pneumonia/ventilator-associated pneumonia caused by designated susceptible bacteria in February 2018.
This is the first FDA approval of a pediatric indication for cUTI and cIAI in more than a decade, the company said.
"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,"Allergan chief research and development officer David Nicholson said. "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."
Avycaz was first approved by the FDA in February 2015 for the treatment of cUTI, including pyelonephritis, and cIAI in combination with metronidazole caused by designated susceptible bacteria, including certain Enterobacteriaceae and P. aeruginosa, for patients age 18 years old and older. Avycaz was subsequently approved for the treatment of adults with hospital-acquired pneumonia/ventilator-associated pneumonia caused by designated susceptible bacteria in February 2018.