An advisory panel for the US Food and Drug Administration (FDA) has approved drug maker Actavis plc for its investigational antibiotic, named ceftazidime-avibactam, for treating severe lower abdominal infections caused by the drug resistant pathogens.
Pharmaceutical company Actavis has announced that the FDA’s Anti-Infective Drugs Advisory Committee has strongly recommended ceftazidime-avibactam to treat infections like complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI) and acute pyelonephritis. The drugs will be administered in combination with the antibiotic metronidazole for patients in hospitals with limited treatment options available.
The committee took the decision after the clinical and scientific trials showed promising result to treat the complicated bacterial infections.
The results, presented by Actavis subsidiary Cerexa, Inc., showed ceftazidime-avibactam as a safe and effective medication to treat cIAI and cUTI caused by gram-negative bacteria, which are resistant to many drugs as well as commonly available antibiotics as well.
David Nicholson, Senior Vice President of Actavis Global Brands Research and Development, said, “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 the combination of hospital-acquired bacterial pneumonia (HABP) / ventilator-associated bacterial pneumonia (VABP) and bacteremia.”
The FDA panel, however, denied approval to the company for the use of ceftazidime-avibactam in treating hospitalized patients with bacteremia, hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP).
Now, all eyes are set on the health regulatory authority that is expected to take the final call on ceftazidime-avibactam New Drug Application (NDA) in the first quarter of 2015.