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    FDA approves new antibiotic combo for two complicated infections

    Kathryn WheelerKathryn WheelerCeftolozane/tazobactam (Zerbaxa; Cubist Pharmaceuticals) received FDA approval in December 2014. This medication is a combination of a new cephalosporin type of antibiotic and a beta-lactamase inhibitor. The bactericidal agent ceftolozane binds penicillin-binding proteins, inhibiting cell-wall synthesis. Tazobactam is a beta-lactamase inhibitor. In combination with ceftolozane, it increases the spectrum of activity to include some bacteria that produce beta-lactamase and would otherwise resist ceftolozane’s antimicrobial activity. 

    Ceftolozane/tazobatam was approved for the treatment of two types of complicated infections: urinary tract infections, including pyelonephritis, and — in combination with metronidazole — intra-abdominal infections. As many infections have become more difficult to treat due to the increase in antibiotic resistance, the Infectious Disease Society of America implemented the “10 by 20” initiative, which calls for 10 new antibiotics to be developed by the year 2020. This drug, the fifth new antibiotic to be approved, offers a new option for fighting resistant pseudomonal infections. 

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    FDA based its approval for use of the drug combination in treatment of intra-abdominal infections on a single study comparing ceftolozone/tazobactam plus metronidazole to meropenem in 979 participants hospitalized with complicated intra-abdominal infections. The primary endpoint, clinical response, was measured at 24 to 32 days after the first dose of study drug was administered. Ceftolozone/tazobactam plus metronidazole was demonstrated to be non-inferior to meropenem.

    While ceftolozone/tazobactam provides excellent coverage against Pseudomonas aeruginosa, it has limited anaerobic activity.  For this reason, it is used in combination with metronidazole in the treatment of intra-abdominal infections.  

    Approval for its use in treatment of complicated urinary infections was based on the findings of a single study in 1,068 adults randomized to receive ceftolozane/tazobactam or levofloxacin. The primary endpoint was defined as the resolution or marked improvement of symptoms and eradication of microbial infection at the test-of-cure visit. This visit occurred within one week (+/- 2 days) of administration of the last dose of study drug. Ceftolozane/tazobactam demonstrated comparable efficacy to levofloxacin in the treatment of complicated urinary tract infections.

    Ceftolozane/tazobactam was designated a Qualified Infectious Disease Product (QDIP) as allowed by the Generating Antibiotic Initiatives Now (GAIN) title of the FDA Safety and Innovation Act.  In accordance with these rules, FDA approved ceftolozane/tazobactam on the basis of a priority and expedited review, because the drug is an antimicrobial product intended to treat serious or life-threatening infections.

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    Kathryn Wheeler, PharmD, BCPS
    Kathryn Wheeler, PharmD, BCPS, is assistant clinical professor of pharmacy practice, University of Connecticut School of Pharmacy, ...


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