Allergan PLC said the U.S. Food and Drug Administration approved its application to expand the label of Avycaz to include children and infants with certain infections aged 3 months and up.
The Dublin-based pharmaceutical company said Avycaz, or ceftazidime and avibactam, can now be used to treat pediatric patients with complicated intra-abdominal infections, or cIAI, in combination with metronidazole, and complicated urinary tract infections, or cUTI. The FDA approval is the first such for children in these indications in more than a decade, the company added.
Pfizer Inc. jointly develops ceftazidime and avibactam with Allergan and holds the rights to commercialize the drug globally as Zavicefta, except in North America.
The approval of the label expansion was based on results from two studies that evaluated Avycaz in children or infants with cIAI or cUTI, as well as a single-dose pharmacokinetic study.
The cIAI trial evaluated the safety and effectiveness of Avycaz plus metronidazole, sold by Sanofi as Flagyl, in comparison with meropenem, an antibiotic marketed by AstraZeneca PLC as Merrem. In the cUTI study, Avycaz was compared with cefepime, sold by Hospira Inc. as Maxipime.
Avycaz first received FDA approval in February 2015 for treating cUTI including pyelonephritis, an inflammation of the kidney, and cIAI in combination with metronidazole, caused by designated susceptible bacteria for patients 18 years old and up. The drug was subsequently approved to treat adults with hospital-acquired pneumonia and ventilator-associated pneumonia caused by designated susceptible bacteria.