Combo Inhibitor Antibiotic Approved to Treat HABP/VABP

The US Food and Drug Administration (FDA) has approved Allergan's supplemental New Drug Application (sNDA) to expand the approved use of their cephalosporin / beta-lactamase inhibitor combo antibiotic, 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 approval is the first Gram-negative antibiotic approved in the United States to treat HABP/VABP in more than 15 years, according to a press release from Allergan.

The antibiotic was originally approved to treat complicated intra-abdominal infections (cIAI) and complicated urinary tract infection (cUTI) in February 2015 in combination with metronidazole. It was approved in 2017 for complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Gram-negative bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa. Subsequent testing on the efficacy of the antibiotic to treat other types of infections proved positive and led to the submission of the sNDA for HABP/VABP.

As Contagion® previously reported, studies have shown a “susceptibility rate of 94.6% and an MIC90 of 8 μg/mL against Pseudomonas aeruginosa isolates for AVYCAZ, [as well as] susceptibility to 99.9% of Klebsiella pneumoniae isolates overall (MIC90 .5 μg/mL) and extended spectrum beta-lactamase-producing Klebsiella pneumoniae isolates (MIC90 2 μg/mL), 99.7% of all Enterobactercloacae isolates (MIC90 1 μg/mL), and 92.0% of ertapenem-resistant Enterobactercloacae isolates (MIC90 8 μg/mL).”

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