Allergan Gets FDA Approval Of sNDA To Update Label For AVYCAZ

Allergan plc AGN disclosed that the Food and Drug Administration has approved its supplemental New Drug Application (sNDA) to update the label for AVYCAZ , i.e. ceftazidime and avibactam. The move follows with clinical data from a final stage study assessing the safety and efficacy of AVYCAZ, in alliance with metronidazole, for the treatment of complicated intra-abdominal infections caused by designated susceptible microorganisms.

Allergan said the approved label contained data from a subset of patients in this study with infections due to ceftazidime-nonsusceptible (CAZ-NS) pathogens, and a subset, which had pathogens producing certain extended-spectrum beta-lactamases.

The company's Chief R&D Officer, David Nicholson, commented, "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 limited treatment options."

He continued, "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."

On Thursday, the stock traded 0.70 percent up.