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:

,

,

,

,

,

, and

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

from Allergan.

Klebsiella pneumoniaeEnterobacter cloacaeEscherichia coliSerratia marcescensProteus mirabilisPseudomonas aeruginosaHaemophilus influenzaepress release

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

. 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.

Pseudomonas aeruginosa

As

, studies have shown a “susceptibility rate of 94.6% and an MIC

of 8 μg/mL against

isolates for AVYCAZ, [as well as] susceptibility to 99.9% of

isolates overall (MIC

.5 μg/mL) and extended spectrum beta-lactamase-producing

pneumoniae isolates (MIC

2 μg/mL), 99.7% of all

isolates (MIC

1 μg/mL), and 92.0% of ertapenem-resistant

isolates (MIC

8 μg/mL).”

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.

Contagion^®previously reported₉₀Pseudomonas aeruginosaKlebsiella pneumoniae₉₀Klebsiella₉₀Enterobactercloacae₉₀Enterobactercloacae₉₀ContagionLive.com