BioCentury
ARTICLE | Clinical News

Avycaz regulatory update

February 3, 2017 12:01 AM UTC

FDA approved an sNDA from Allergan for Avycaz ceftazidime/avibactam to include data from the Phase III RECAPTURE and REPRISE trials of the drug to treat complicated urinary tract infections (cUTIs) caused by susceptible Gram-negative bacteria. Data from the double-blind RECAPTURE trial in 1,020 patients hospitalized with cUTI showed that Avycaz was non-inferior to doripenem on the co-primary endpoints of patient-reported symptomatic response at day 5 (70.2% vs. 66.2%) and combined patient-reported symptomatic response and microbiological cure at the test-of-cure (TOC) visit (71.2% vs. 64.5%) in the microbiological modified intent-to-treat (mMITT) population (see BioCentury, Sept. 7, 2015). Data from the open-label REPRISE trial in 305 patients with cUTI due to ceftazidime-resistant Gram-negative pathogens showed that the combined clinical and microbiological cure rate at days 21-25 in the mMITT population was higher in patients treated with Avycaz vs. those treated with best available therapy (70.1% vs. 54%)...

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Allergan plc

Pfizer Inc.

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Beta lactamase (LACTB)