An advisory panel for the U.S Food and Drug Administration (FDA) has given the greenlight on a new investigational drug for treating two infections caused by drug-resistant pathogens.
Pharmaceutical company Actavis announced on Dec. 5 that the Anti-Infective Drugs Advisory Committee advising the FDA has agreed to recommend the approval of the drug ceftazidime-avibactam for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis, and intra-abdominal infections (cIAI), in combination with the antibiotic metronidazole in hospitalized patients with limited treatment options available.
The committee's decision was based on the clinical and scientific evidence presented by Actavis subsidiary Cerexa, Inc., which showed ceftazidime-avibactam as a safe and effective treatment for cIAI and cUTI caused by gram-negative bacteria.
These pathogens are resistant to many drugs and increasingly become resistant to commonly available antibiotics as well. Gram-negative pathogens are highly adaptive. They find new ways to develop resistance and transmit genetic material that can give way for other bacteria to become drug-resistant as well. Complicated urinary tract infections are often attributed to drug-resistant bacteria.
Escherichia coli (E. coli) commonly causes urinary tract infections (UTIs) affecting nearly 3 million people per year. This pathogen has notably become resistant to currently available antibiotics. Data from the National Healthcare Safety Network (NHSN) of the Centers for Disease Control and Prevention (CDC) show that in 2008, 13 percent of E.coli infections in intensive care units were multi-drug resistant.
The advisory committee, however, did not recommend the use of ceftazidime-avibactam as treatment for hospital-acquired bacterial pneumonia (HABP) and bacteremia due to inadequate evidence. The advisory group likewise raised concerns about the use of the antibiotic in patients with renal impairment.
"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," Actavis Global Brands Research and Development Senior Vice President David Nicholson stated.
The FDA is not required to adopt the recommendations of the advisory committee. The agency will also decide whether or not to greenlight ceftazidime-avibactam. Actavis awaits the FDA's decision in the first quarter next year.
Ceftazidime-avibactam is developed by Ireland-based Actavis in collaboration with British biologics company AstraZeneca for treating serious infections caused by drug-resistant bacteria, including multidrug-resistant (MDR) Pseudomonasaeruginosa and carbapenem-resistant Enterobacteriaceae (CRE).
