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news.The US Food and Drug Administration (FDA) has granted approval for Actavis' antibacterial drug Avycaz (ceftazidime-avibactam) to treat adult patients with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI).
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The drug is also indicated to treat pyelonephritis caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa.
Owned by Actavis, Avycaz is a combination of a previously approved antibacterial drug ceftazidime, and avibactam, which is being co-developed with AstraZeneca.
In North America, Actavis owns rights to commercialize the drug, while AstraZeneca holds its commercialization rights in the rest of the world.
The FDA granted priority review for Avycaz based on Phase II data from the company’s clinical development program and supporting in vitro data.
Actavis Global Brands Research and Development executive vice-president David Nicholson said: "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."
Ceftazidime is a cephalosporin with in vitro activity against certain Gram-negative and Gram-positive bacteria, while avibactam is a non-beta-lactam beta-lactamase inhibitor that inactivates certain key beta-lactamases and protects ceftazidime from degradation by these beta-lactamases.
The approval was supported in part by the FDA’s previous findings of efficacy and safety for ceftazidime to treat cIAI and cUTI.
Additionally, the contribution of avibactam to Avycaz was primarily established through in vitro data and animal models of infection.
The company said that the antibacterial drug Avycaz will be available in the second quarter of 2015.