The FDA today approved ceftazidime-avibactam, an antibacterial drug for patients with complicated intra-abdominal infections, in combination with metronidazole, and complicated urinary tract infections.
The FDA today approved ceftazidime-avibactam (Avycaz), an antibacterial drug for patients with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections.
Actavis’s Avycaz is for adults with limited or no alternative treatment options.
One component of Avycaz, ceftazidime, had already been approved by the FDA for cIAI and cUTI, but the addition of avibactam was based on data from in vitro studies and animal models of infection. Avycaz was used in 2 phase 2 trials—1 each in cIAI and cUTI, according to the FDA.
Common side effects include vomiting, nausea, constipation, and anxiety.
For patients with poor kidney function, health care professionals should counsel patients that they may also experience seizures and decreased efficacy of Avycaz, according to the FDA. Patients with penicillin allergies may also experience serious skin reactions and anaphylaxis.
“The FDA is committed to making therapies available to treat patients with unmet medical need,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”