allergan

FDA approves expanded label for Allergan’s Avycaz

pharmafile | June 24, 2016 | News story | Medical Communications, Research and Development, Sales and Marketing Allergan, Avycaz, FDA, expanded label 

Allergan (NYSE: FDA) has announced that the US Food and Drug Administration (FDA) has approved its supplemental new drug application for an expanded label for Avycaz (ceftazidime and avibactam), for the treatment of complicated intra-abdominal infections.

This expanded label is based on Phase III data showing the efficacy and safety of Avycaz, in combination with metronidazole, in these infections caused by designated susceptible microorganisms. In this study, Avycaz met the primary endpoint of statistical non-inferiority to meropenem in terms of clinical cure rates.

The FDA approved the drug in 2015, and this new label also contains data from a subset of patients in this trial with infections due to ceftazidime-non susceptible pathogens, as well as a subset who had pathogens producing certain extended-spectrum beta-lactamases.

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David Nicholson, chief R&D officer at Allergan, says: “Complicated intra-abdominal infections represent a major therapeutic challenge for physicians. 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 no treatment options.”

Sean Murray

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