FDA approves Allergan's sNDA for Avycaz to include new Phase III data in patients with cUTI

New clinical data for Avycaz demonstrates efficacy in cUTI patients including those with infections due to resistant Gram-negative pathogens.

In Trial 1, known as RECAPTURE, Avycaz was non-inferior to doripenem with regard to both primary endpoints. In Trial 2, known as REPRISE, Avycaz demonstrated a higher combined clinical and microbiological cure rate vs. best available therapy (BAT), including meropenem, imipenem, doripenem, and colistin. Additionally, both trials included a subset of patients with infections caused by pathogens producing certain ESBL groups and AmpC beta-lactamases in which the clinical and microbiological cure rates were similar to the overall results.

The prevalence of infections caused by resistant Gram-negative bacteria, specifically extended spectrum beta-lactamase (ESBL) and Klebsiella pneumoniae carbapenamase (KPC)-producing carbapenem-resistant Enterobacteriaceae (CRE), and resistant Pseudomonas aeruginosa have steadily increased in recent years; this has led the US Centers for Disease Control and Prevention (CDC) to classify these pathogens as urgent and serious public health threats, as there are very limited treatment options.

"Gram-negative pathogens are among the most urgent antibiotic resistance threats and cause more than 40,000 resistant infections in the US each year," said David Nicholson, Chief R&D Officer, Allergan. "This new sNDA approval for Avycaz is based on a large clinical database, comprising data from more than 1,300 patients with cUTI across Phase III studies, including a number of patients with infections due to ceftazidime non-susceptible (CAZ-NS) pathogens. It provides physicians with further clinical evidence that will assist them in making informed treatment decisions for their patients with cUTI, including those with difficult to treat pathogens."

"The successful cumulative Phase III cUTI studies further validate the initial FDA approval of Avycaz based on Phase II data. The inclusion of the REPRISE data in the label represents a significant advancement in the available data to support efficacy in cUTI patients infected with challenging pathogens, including certain ESBL and KPC-producing Enterobacteriaceae, reinforcing Allergan's leadership in responding to some of the most challenging infections facing our society today."