FDA Approves New Combination Antibacterial Drug

A new antibacterial drug has been approved by the US Food and Drug Administration for the treatment of complicated intra-abdominal infections and complicated urinary tract infections.

A new antibacterial drug has been approved by the US Food and Drug Administration (FDA) for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).

Zerbaxa (ceftolozane/tazobactam), combines a cephalosporin antibacterial and a beta-lactamase inhibitor and is the fourth antibacterial drug which has been approved by the FDA this year, joining Dalvance (dalbavancin), Sivextro (tedizolid), and Orbactiv (oritavancin).

“The FDA approval of several new antibacterial drugs this year demonstrates the agency’s commitment to increasing the availability of treatment options for patients and physicians,” noted Edward Cox, MD, MPH, director of the office of Antimicrobial Products in the FDA Center for Drug Evaluation and Research in a statement. “We must continue to help foster the development of new antibacterial drugs and encourage prudent use of existing treatments to conserve their utility.”

Approval for treating cIAI came after a clinical trial of 979 adults in combination with metronidazole. Some participants were given either Zerbaxa and metronidazole or meropenem, which is an antibacterial drug which had been previously approved. The new drug combined with metronidazole was proven to be effective in treating patients with cIAI.

For the treatment of cUTI, the drug was tested in a patient group of 1068 adults who were either given Zerbaxa or levofloxacin. Study results established that Zerbaxa was an effective treatment option.

The label for Zerbaxa also includes a warning about its reduced efficacy in patients with renal impairment, according to the FDA. Common side effects during testing were nausea, diarrhea, headache, and fever.

The drug was approved as part of the FDA’s Qualified Infectious Disease Product process “because it is an antibacterial or antifungal human drug intended to treat a serious or life threatening infection,” the statement added. As part of the program the drug was given priority review and qualified Zerbaxa for 5 more years of marketing exclusivity.

Zerbaxa and Sivextro are marketed by Cubist Pharmaceuticals, Dalvance is marketed by Durata Therapeutics and Orbactive is marketed by The Medicines Company.