Pharmaceutical company Allergan plc (NYSE:AGN) reported on Thursday the receipt of approval from the US Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for the expanded use of AVYCAZ for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP).

The company said the expanded use of AVYCAZ (ceftazidime and avibactam) includes 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 follows the positive results from the company's pivotal Phase 3 study that evaluated the efficacy and safety of AVYCAZ for treating adult patients with HABP/VABP. The sNDA received priority review based on the Qualified Infectious Disease Product designation for the HABP/VABP indication.

According to the company, AVYCAZ consists of a combination of avibactam and ceftazidime. Avibactam is a first-in-class non-beta-lactam beta-lactamase inhibitor which protects ceftazidime against degradation by certain beta-lactamases.. Ceftazadime is a third-generation cephalosporin with a well-established efficacy and safety profile.

About 870 hospitalised adult patients with HABP or VABP were randomised and received trial medications in a pivotal Phase 3, multinational, double-blind trial comparing AVYCAZ 2.5 g intravenously every eight hours to meropenem 1 gram intravenously, added the company.

In conjunction, the primary efficacy endpoint of the company's study was 28-day all-cause mortality in the ITT population. The 28-day all-cause mortality in patients with ceftazidime non-susceptible Gram-negative isolates was 8.2% in the AVYCAZ arm and 8.5% in the meropenem arm.