Actavis Receives FDA Approval for Avycaz

Actavis has announced the FDA has approved Avycaz (ceftazidime-avibactam). Avycaz was approved 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. Avycaz received a priority review based on Phase II data from the company's clinical development programme and supporting in vitro data, and as such should be reserved for use in patients who have limited or no alternative treatment options.

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.

"The FDA approval of Avycaz is an important step forward in enhancing our ability to respond to serious infections caused by difficult to treat Gram-negative pathogens," said David Nicholson, Executive Vice President, Global Brands Research and Development, Actavis. "At Actavis, we are dedicated to helping bridge the gap in existing treatment options, and the development of new agents that may help address the urgent threat of these pathogens. We were very pleased to be working with the FDA to advance the approval of Avycaz as quickly as possible to make this important new treatment option available to physicians and patients at the earliest possible time."

Avycaz was granted priority review and approval as a Qualified Infectious Disease Product in accordance with the Generating Antibiotics Incentives Now (GAIN) Act, which made it eligible for the FDA's fast-track programme and a 5-year regulatory extension of exclusivity under the Hatch-Waxman Act.

"The recent increase in the incidence of multi-drug resistant Gram-negative pathogens poses a significant threat to patients and places a tremendous strain on the U.S. healthcare system. The increasing prevalence of KPC-producing Enterobacteriaceae in particular, have become a major therapeutic challenge for physicians managing these infections. Unfortunately, there are currently a limited number of safe and effective antimicrobials to treat these serious infections," said Jose Vazquez, Professor of Medicine, Chief, Infectious Diseases and Chair of the Antimicrobial Subcommittee at the Medical College of Georgia/Georgia Regents University.

The approval of Avycaz was supported in part by the FDA's previous findings of efficacy and safety for 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 Phase II studies were not designed with any formal hypotheses for inferential testing against the active comparators.

Avycaz will be available in the second quarter of 2015.