FDA approves extended indication for Avycaz in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.- Allergan.

The FDA has approved the supplemental New Drug Application (sNDA) to expand the approved use of Avycaz (ceftazidime and avibactam), from Allergan, 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 expanded use is based on positive results from a pivotal Phase III study evaluating the efficacy and safety of Avycaz for the treatment of adult patients with HABP/VABP. Clinical efficacy was evaluated in the intent-to treat (ITT) population, which included all randomized patients who received study drug. Overall, 379 (43.6%) patients were ventilated at enrollment, including 290 (33.3%) patients with VABP and 89 (10.2%) with ventilated-HABP. Bacteremia at baseline was present in 4.8% of patients.

The primary efficacy endpoint of the study was 28-day all-cause mortality (28 to 32 days after randomization) in the ITT population. The study successfully demonstrated that Avycaz was non-inferior to meropenem with respect to the primary endpoint based on a 10% non-inferiority margin; the 28-day all-cause mortality rate was 9.6% (42/436) in patients treated with Avycaz compared with 8.3% (36/434) in meropenem treated patients (treatment difference of 1.5%; 95% confidence interval [CI]: -2.4, 5.3). The sNDA received priority review from FDA based on the Qualified Infectious Disease Product (QIDP) designation for the HABP/VABP indication.