FDA Advisory Committee votes in favor of Actavis' ceftazidime-avibactam

Actavis plc (NYSE: ACT) today announced that the Anti-Infective Drugs Advisory Committee convened by the U.S. Food and Drug Administration (FDA) has voted to recommend approval of Actavis' New Drug Application (NDA) for ceftazidime-avibactam, an investigational antibiotic being developed to treat hospitalized patients when limited or no treatment options are available for complicated intra-abdominal infections (cIAI) (in combination with metronidazole) and complicated urinary tract infections (cUTI) (including acute pyelonephritis) caused by Gram-negative pathogens.

The committee found the scientific and clinical evidence submitted by Cerexa, Inc., a wholly owned subsidiary of Actavis, adequately demonstrated the safety and efficacy of ceftazidime-avibactam in the treatment of the proposed cIAI and cUTI indications. The committee voted not to recommend approval of the combination for hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP) and bacteremia.

"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, Global Brands Research and Development, Actavis. "As public health officials continue to sound the alarm on antibiotic-resistant infections, Actavis remains committed to advancing the ceftazidime-avibactam clinical development program, including for the combination of hospital acquired bacterial pneumonia (HABP)/ ventilator-associated bacterial pneumonia (VABP) and bacteremia, and working closely with the FDA as it completes its review of our New Drug Application."

Ceftazidime-avibactam inhibits a broad range of β- lactamases, including Class A (Extended-Spectrum β-Lactamases and Klebsiella pneumoniae carbapenemase), Class C (AmpC) and some class D enzymes produced by Gram-negative pathogens that are encountered in the hospital setting and involved in some of the most serious infections like cIAI and cUTI.

The Advisory Committee recommendation is not binding on the FDA, which makes the final decision regarding approval. Actavis expects FDA action on its NDA for ceftazidime-avibactam during the first quarter of 2015.