After positive results regarding Avycaz’s treatment of HABP/VABP in adult patients, Allergan is seeking to gain FDA approval for the drug.
The multicenter, randomized double-blind REPROVE study demonstrated the non-inferiority of Avycaz to meropenem with regard to the US FDA primary endpoint, 28-day all-cause mortality in the ITT (intent-to-treat) population, and Avycaz was also non-inferior to meropenem with respect to the key secondary endpoint, clinical cure at the test of cure (TOC) visit in the ITT population.
In a subset of patients infected with Gram-negative pathogens producing certain ESBL group and AmpC beta-lactamases, the clinical and microbiological cure rates were similar to the overall results. In the study, the overall safety profile observed for AVYCAZ was consistent with the current product labeling.
