FDA Expands Indication of Antibacterial Drug

The FDA has expanded the approval of Avycaz (ceftazidime and avibactam) to include treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae in patients 18 years of age or older.

The expanded approval was based upon the results of a Phase 3 study that evaluated the efficacy and safety of the drug for the treatment of patients with HABP/VABP involving 870 hospitalized adults.

Avycaz was first approved in February 2015 for the treatment of adult patients with complicated intra-abdominal infections, in combination with metronidazole, and was expanded in 2017 to include treatment of complicated urinary tract infections, including pyelonephritis, caused by designated susceptible Gram-negative bacteria.

Potential adverse reactions include diarrhea and vomiting.

—Michael Potts

Reference:

https://www.allergan.com/news/news/thomson-reuters/fda-approves-avycaz-ceftazidime-and-avibactam-for [press release]. Allergan. February 1, 2018.