Ceftazidime/avibactam regulatory update

Actavis said FDA’s Anti-Infective Drugs Advisory Committee recommended approval of an NDA for ceftazidime/avibactam to treat complicated urinary tract infections (cUTIs) and in combination with metronidazole to treat complicated intra-abdominal infections (cIAI), both of which are caused by Gram-negative pathogens. The committee recommended against approval of the antibiotic to treat aerobic Gram-negative bacterial infections with limited treatment options, including hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP), and bacteremia where limited or no alternative therapies are available. Actavis expects a decision on the NDA next month.

AstraZeneca plans to submit an MAA to EMA this quarter for the product -- a broad-spectrum beta lactamase (LACTB) inhibitor combined with ceftazidime, a third-generation cephalosporin. Ceftazidime/avibactam has Qualified Infectious Disease Product (QIDP) designation from FDA for cIAI, cUTI and HABP/VABP. ...