Posted by Michael Wonder on 02 Feb 2018
FDA approves Avycaz (ceftazidime and avibactam) for the treatment of patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
1 February 2018 - First gram-negative antibiotic approved in the U.S. to treat HABP/VABP in over 15 years.
Allergan today announced that the U.S. FDA has approved Allergan's supplemental new drug application to expand the approved use of Avycaz (ceftazidime and avibactam) to include the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the following susceptible Gram-negative microorganisms: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae in patients 18 years of age or older.
This expanded use is based on positive results from a pivotal Phase 3 study evaluating the efficacy and safety of Avycaz for the treatment of adult patients with HABP/VABP. The application received priority review from FDA based on the qualified infectious disease product designation for the HABP/VABP indication.
