The US Food and Drug Administration (FDA) has approved a new dual antibacterial for complicated intra-abdominal infections (cIAIs) and complicated urinary tract infections (cUTIs) in adults.
Zerbaxa, from Cubist Pharmaceuticals, combines the cephalosporin antibacterial ceftolozane and the beta-lactamase inhibitor tazobactam. It is the fourth new antibacterial drug approved by the FDA this year.
As previously reported by Medscape Medical News, the FDA approved dalbavancin (Dalvance, Durata Therapeutics) in May, tedizolid (Sivextro, Cubist) in June, and oritavancin (Orbactiv, The Medicines Co) in August.
"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," said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. "We must continue to help foster the development of new antibacterial drugs and encourage prudent use of existing treatments to conserve their utility."
The efficacy of Zerbaxa for the treatment of cIAIs in combination with metronidazole was demonstrated in a clinical trial involving 979 adults. Participants were randomly assigned to receive Zerbaxa plus metronidazole or the antibacterial meropenem. "Results showed Zerbaxa plus metronidazole was effective for the treatment of cIAI," the FDA says.
The efficacy of Zerbaxa for cUTIs was established in a study of 1068 adults randomly assigned to Zerbaxa or levofloxacin. "Zerbaxa demonstrated it was effective in treating cUTI," the FDA notes.
The most common adverse effects identified in the clinical trials were nausea, diarrhea, headache, and fever (pyrexia). The Zerbaxa label includes a warning about decreased efficacy seen in patients with renal impairment.
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Cite this: FDA OKs Combination Antibacterial Zerbaxa - Medscape - Dec 22, 2014.