Allergan’s to update label on its antibiotic Avycaz

Allergan has ensured permit to update the label for its antibiotic Avycaz with new data from two third phase clinical trials, about treatining patients with certain complicated urinary tract infections (UTI).

The company announced on Monday that th eU.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for updating Avycaz label.

The sNDA approval for Avycaz is based on two phase three clinical testing data which was conducted with more than 1,300 patients with cUTI. A certain number of patients had ceftazidime non-susceptible (CAZ-NS) pathogens infections.

The drugmaker further explained that the increasing number of infections caused by certain resistant Gram-negative bacteria, in recent years, has led the U.S. Centers for Disease Control and Prevention (CDC) to classify those pathogens as urgent and serious public health threats, as there are very limited treatment options.

“Gram-negative pathogens are among the most urgent antibiotic resistance threats and cause more than 40,000 resistant infections in the U.S. alone each year,” said David Nicholson, Ph.D., Chief R&D Officer, Allergan.

Allergan about About AVYCAZTM
Avycaz is an antibiotic developed to treat certain serious Gram-negative bacterial infections. It consists of ceftazidime, a third-generation, cephalosporin, that is an established and respected treatment for serious Gram-negative bacterial infections, and avibactam, a non-ß lactam ß-lactamase inhibitor.