FDA panel recommends Actavis' antibiotic for approval

Actavis Plc has announced that the Infective Drugs Advisory Committee has voted to recommend approval of its New Drug Application for ceftazidime-avibactam.

Ceftazidime-avibactam is an investigational antibiotic being developed to treat serious gram-negative bacterial infections. The Centers for Disease Control and Prevention (CDC) has recognized gram-negative pathogens as increasingly problematic because they are becoming resistant to nearly all antibiotics routinely used for treatment. Ceftazidime is a third-generation, antipseudomonal cephalosporin that is a well-established option for the treatment of gram-negative infections, and avibactam is a next-generation beta-lactamase inhibitor used to protect ceftazidime from enzymatic breakdown.

Because of clinical evidence submitted by Cerexa, a subsidiary of Actavis, the advisory committee deemed ceftazidime-avibactam safe and effective to treat complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI) caused by gram-negative pathogens when little or no treatment options are available. However, the committee did not vote to approve the drug for use in treating hospital-acquired bacterial pneumonia (HABP) or bacteremia. The panel also raised concerns regarding labeling, particularly for patients with renal impairment.

"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," David Nicholson, senior vice president, Global Brands Research and Development, Actavis, said in a press release.

Actavis expects the FDA’s final decision regarding the approval of its NDA for ceftazidime-avibactam during the first quarter of 2015.

Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.