Regulatory Affairs

FDA approves label update to Allergan's Avycaz

PBR Staff Writer Published 31 January 2017

The US Food and Drug Administration (FDA) has approved Allergan’s supplemental New Drug Application (sNDA)for Avycaz to include new phase III data in patients with complicated urinary tract infections (cUTI), including Pyelonephritis.

The approval is based on a large clinical database, comprising data from over 1,300 patients with cUTI across phase 3 studies, including several patients with infections due to ceftazidime non-susceptible (CAZ-NS) pathogens.

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

In one trial, known as Recapture, Avycaz proved non-inferior to doripenem with regard to both primary endpoints in the microbiologically modified intent-to-treat (mMITT) population.

The symptomatic response rate at Day 5 in the Avycaz-treated patients was 70.2% vs. 66.2% in doripenem-treated patients.

The combined symptomatic and microbiological response rate at Test of Cure (TOC) in the Avycaz-treated patients was 71.2% vs. 64.5% in doripenem-treated patients. 

In an another trial, Reprise, Avycaz showed a higher combined clinical and microbiological cure rate versus best available therapy, including meropenem, imipenem, doripenem, and colistin.

The combined clinical and microbiological cure rate at Days 21 to 25 in the mMITT population was higher in Avycaz-treated patients than in patients on best available therapy (BAT).

The combined cure rates were 70.1% for Avycaz-treated patients and 54% for BAT-treated patients.

Avycaz was first approved in the US in February 2015 to treat adult patients with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and cUTI, including pyelonephritis, caused by designated susceptible pathogens, including certain Enterobacteriaceae and Pseudomonas aeruginosa.

Image: Allergan headquarters in Irvine. Photo: courtesy of Coolcaesar at en.wikipedia.