The FINANCIAL — Actavis plc on April 23 announced AVYCAZ (ceftazidime-avibactam) is now available for ordering by hospitals across the United States. AVYCAZ is indicated for the treatment of adult patients with complicated intra-abdominal infections (cIAI) (in combination with metronidazole) and complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa.
As only limited clinical safety and efficacy data for AVYCAZ are currently available, AVYCAZ should be reserved for use in patients who have limited or no alternative treatment options, according to Actavis.
“In light of the urgent medical need in the U.S. for new antimicrobial treatments that address some of the most difficult to treat pathogens, Actavis increased the company’s manufacturing focus to ensure AVYCAZ would be available as soon as possible following FDA approval,” said William Meury, President, Actavis Branded Pharma. “We are proud to provide healthcare providers with this new therapeutic option that addresses serious Gram-negative infections for which there are few treatment options today.”
AVYCAZ combines ceftazidime, a cephalosporin with in vitro activity against certain Gram-negative and Gram-positive bacteria, and avibactam, a non-beta-lactam beta-lactamase inhibitor that inactivates certain key beta-lactamases and protects ceftazidime from degradation by these beta-lactamases. The addition of avibactam to ceftazidime protects ceftazidime from breakdown by Extended Spectrum Beta-Lactamases (ESBL), Klebsiella pneumoniae carbapenemase (KPC) and AmpC producing pathogens. AVYCAZ is part of Actavis’ leading portfolio of infectious disease products that address some of the most dangerous pathogens.
AVYCAZ received a priority review and FDA approval was supported in part by the FDA’s previous findings of efficacy and safety of ceftazidime for the treatment of cIAI and cUTI. In addition, the contribution of avibactam to AVYCAZ was primarily established via in vitro data and animal models of infection. AVYCAZ was studied in two Phase II, randomized, blinded, active controlled, multicenter trials, one each in cIAI and cUTI, including pyelonephritis. These studies were not designed with any formal hypotheses for inferential testing against the active comparators.
AVYCAZ for injection is supplied in single-use, clear glass vials for reconstitution. It is available to hospitals for purchase in cartons of ten (10) 2.5 g vials.
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