5 February 2018 - - The US Food and Drug Administration has approved Dublin, Ireland-based specialty pharmaceutical company Allergan plc's (NYSE: AGN) supplemental new drug application to expand the approved use of Avycaz (ceftazidime and avibactam) to include the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae in patients 18 years of age or older, the company said.
This expanded use is based on positive results from a multinational, double-blind Phase 3 study evaluating the efficacy and safety of Avycaz in 870 hospitalized adult patients with HABP/VABP.
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% in patients treated with Avycaz compared with 8.3% in meropenem treated patients.
Avycaz demonstrated a safety profile consistent with that observed in prior clinical trials with Avycaz and with the established safety profile for ceftazidime alone. The most common adverse reactions in HABP/VABP patients were diarrhea and vomiting.
Avibactam is a non-beta-lactam beta-lactamase inhibitor which protects ceftazidime, a third-generation cephalosporin, against degradation by certain beta-lactamases without decreasing the activity of ceftazidime against ceftazidime-susceptible organisms.
Ceftazidime and avibactam is being jointly developed with Pfizer. Allergan holds the rights to commercialize ceftazidime and avibactam in North America under the brand name Avycaz, while Pfizer holds the rights to commercialize the combination in the rest of the world under the brand name Zavicefta.
Allergan is a global pharmaceutical company focused on developing, manufacturing and commercialising branded pharmaceuticals, devices, and biologic products for patients around the world.
The company markets a portfolio of products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.