FDA panel recommends Actavis' antibiotic for approval

December 8, 2014

Actavis Plc has announced that the Infective Drugs Advisory Committee, which makes recommendations to the FDA concerning the safety and effectiveness of drug products for use in the treatment of infectious diseases, has voted to recommend approval of its New Drug Application for ceftazidime-avibactam.

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.