Committee Recommends FDA Approval of Antibiotic to Treat Intra-Abdominal Infections, UTIs
The Anti-Infective Drugs Advisory Committee is recommending that the FDA approve of Actavis's new drug application for ceftazidime-avibactam, an investigational antibiotic.
The Anti-Infective Drugs Advisory Committee is recommending that the FDA approve of Actavis’s new drug application for ceftazidime-avibactam, an investigational antibiotic.
The antibiotic is being created to treat hospitalized patients when limited or no treatment options are available for complicated intra-abdominal infections (cIAI), in combination with metronidazole, as well as complicated urinary tract infections (cUTI) caused by gram-negative pathogens, according to an Actavis press release.
While the committee did recommend approval of the antibiotic to treat cIAIs and cUTIs caused by gram-negative pathogens, it thought less of the combination for hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VAPB), and bacteremia and did not recommend it for FDA approval, according to Actavis.
Actavis stated it anticipated a decision from the FDA on the antibiotic in the first quarter of 2015.
"We are pleased with the committee's positive recommendation for ceftazidime-avibactam. It reinforces our belief in the safety and efficacy of the compound and its potential to address significant unmet needs as a new treatment option for patients with serious and life-threatening infections," said David Nicholson, senior vice president of global brands research and development at Actavis, in a press release.
cIAIs affect around 1.1 million people each year, and UTIs, often caused by Escherichia coli, affect around 2.9 million people each year.