FDA approved Allergan's supplemental New Drug Application (sNDA) to expand the approved use of ceftazidime and avibactam (Avycaz) to include 2 types of pneumonia.
Avycaz was first approved in 2015, in combination with metronidazole, to treat adult patients with complicated intra-abdominal infections (cIAI). Then, in 2017, FDA approved the drug for complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Gram-negative bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa.
Now, Avycaz is indicated to treat 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.
“The economic burden associated with HABP/VABP is significant. These infections are associated with increased healthcare costs, high morbidity and mortality, and lengthened hospital stays,” Allergan said in a statement. HABP/VABP is the second most common type of nosocomial infection in the US, especially in the intensive care unit (ICU) of hospitals, according to Allergan.
Plus, certain types of Gram-negative bacteria have become increasingly resistant to available antibiotics, resulting in increased illness and death as well as contributing to escalating healthcare costs, Allergan said.
"Healthcare providers in the US have not had access to a new treatment option for patients with HABP/VABP due to Gram-negative bacteria in over 15 years," said David Nicholson, PhD, chief research and development officer for Allergan, in the statement. "Gram-negative pathogens are some of the most pressing antibiotic resistance threats and cause more than 40,000 resistant infections in the US annually. “
This expanded use is based on positive results from a multinational phase 3 study, which demonstrated that 28-day all-cause mortality rate was 9.6% in patients treated with Avycaz, compared with 8.3% in patients taking meropenem.