Allergan plc announced the U.S. Food and Drug Administration's (FDA) approved the supplemental New Drug Applicaction (sNDA) for AVYCAZ (ceftazidime and avibactam) last week.
The updated label will contain the information from the Phase III trial that combined AVYCAZ with metronidazole. The study evaluated the medication in treating complicated intra-abdominal infections (cIAI). The trial showed improved clinical cure rates for patients suffering from difficult to treat infections resulting from ceftazidine-resistant bacteria and other susceptible bacterium.
"Complicated intra-abdominal infections represent a major therapeutic challenge for physicians," Allergan Chief R&D Officer David Nicholson said. "AVYCAZ has been used in thousands of patients with these difficult-to-treat infections since it was first approved by the FDA in February 2015. The addition of these data to the label provides physicians with consistent evidence of the activity of AVYCAZ against some of the most challenging pathogens, including those for which we currently have limited treatment options."
AVYCAZ and metronidazole are used in combination to treat cIAI and complicated urinary tract infections (cUTI). To prevent bacteria from developing drug resistance, AVYCAZ is recommended for use only with susceptible bacteria, including Escherichia coli, Klebsiella pneumoniae and Proteus spp.
"As a leader in anti-infectives, Allergan is committed to furthering the science needed to address the growing prevalence of these difficult-to-treat infections, helping physicians better understand the threat of challenging pathogens and equipping them with much needed treatments for their patients," Nicholson said.
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