The Food and Drug Administration has approved expanding the indication for the drug combination of ceftazidime and avibactam (Avycaz) to include hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults.
Specifically, the approved indication is for infections caused by certain Gram-negative bacteria – some of which are increasingly resistant to available antibiotics – including, Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae.
There have not been new treatment options for HABP/VABP caused by Gram-negative bacteria in more than 15 years, according to Allergan , the drug’s manufacturer.
The approval of the expanded indication was based on data from the phase 3, multinational, double-blind REPROVE trial . The study showed that ceftazidime/avibactam was noninferior to meropenem with respect to 28-day all-cause mortality.
This is the third approved indication for ceftazidime/avibactam; the other two indications are for complicated intra-abdominal infections (in combination with metronidazole) and for complicated urinary tract infections.