The FDA approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
Zerbaxa is a combination product containing ceftolozane, a cephalosporin antibacterial drug, and tazobactam, a beta-lactamase inhibitor. Zerbaxa is used to treat cUTI, including kidney infection (pyelonephritis). It I used in combination with metronidazole to treat cIAI.
Zerbaxa is the 4th new antibacterial drug approved by the FDA this year. Earlier, the agency approved Dalvance (dalbavancin), Sivextro (tedizolid), and Orbactiv (oritavancin).
Zerbaxa is the fourth new antibacterial drug product designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, Zerbaxa was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat a serious or life-threatening infection.
Zerbaxa’s efficacy to treat cIAI in combination with metronidazole was established in a clinical trial with a total of 979 adults. Participants were randomly assigned to receive Zerbaxa plus metronidazole or meropenem, an FDA-approved antibacterial drug. Results showed Zerbaxa plus metronidazole was effective for the treatment of cIAI.
The efficacy of Zerbaxa to treat cUTI was established in a clinical trial where 1,068 adults were randomly assigned to receive Zerbaxa or levofloxacin, an antibacterial drug approved by the FDA to treat cUTI. Zerbaxa demonstrated it was effective in treating cUTI.
The Zerbaxa label includes a warning about decreased efficacy seen in patients with renal impairment. The most common side effects identified in the clinical trials were nausea, diarrhea, headache and fever (pyrexia).
Zerbaxa and Sivextro are marketed by Cubist Pharmaceuticals, based in Lexington, Massachusetts. Dalvance is marketed by Chicago-based Durata Therapeutics, and Orbactiv is marketed by Parsippany, New Jersey-based The Medicines Company.