FDA clears Actavis' combination antibacterial Avycaz

The FDA announced the approval of Actavis' Avycaz (ceftazidime/avibactam) to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections, who have limited or no alternative treatment options. The product is a fixed-combination containing ceftazidime, a previously approved cephalosporin antibacterial, and avibactam, a new beta-lactamase inhibitor.

Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said "it is important that the use of Avycaz be reserved to situations when there are limited or no alternative antibacterial drugs for treating a patient's infection." The agency noted that Avycaz is the fifth approved antibacterial designated as a Qualified Infectious Disease Product, with Actavis' drug given priority review by the regulator.

The approval of Avycaz was supported by the FDA's previous findings of efficacy and safety for ceftazidime for the treatment of cIAI and cUTI, and followed a positive advisory committee vote in December. In addition, the contribution of avibactam to ceftazidime was established via in vitro data and animal models of infection. Avycaz was also studied in two Phase II trials in cIAI and cUTI. According to Actavis, the addition of avibactam to ceftazidime protects the latter from breakdown by extended spectrum beta-lactamases, Klebsiella pneumoniae carbapenemase and AmpC producing pathogens.

Gabelli & Co analyst Kevin Kedra remarked that Avycaz "has shown good activity against a variety of tough-to-treat infections, and gives doctors another option, especially if their first choice runs into issues of resistance." Kedra highlighted that Actavis estimates that the product, which will be available in the US in the second quarter, will generate peak sales of about $250 million to $500 million.

Avycaz is being jointly developed by Actavis and AstraZeneca, with the former holding commercialisation rights in North America, and the UK drugmaker owning rights in the rest of the world. Phase III studies, including those evaluating Avycaz for the treatment of cIAI and cUTI, are under way and targeted for completion in late 2015. Actavis said it plans to submit the results to the FDA as part of a supplemental filing.

In October last year, Actavis entered a definitive merger agreement to acquire Durata Therapeutics for approximately $675 million, expanding its infectious disease portfolio with the latter's antibiotic Dalvance (dalbavancin).

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