Cubist announced that the Food and Drug Administration (FDA) has approved Zerbaxa (ceftolozane/tazobactam) Injection for the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by susceptible Gram-negative bacteria.

Zerbaxa combines ceftolozane, a cephalosporin antibiotic, and tazobactam, a beta-lactamase inhibitor. Ceftolozane inhibits cell wall biosynthesis and inhibits penicillin-binding proteins of P. aeruginosa and E. coli. Tazobactam is an irreversible inhibitor of some beta-lactamases and can bind covalently to some chromosomal and plasmid-mediated bacterial beta-lactamases.

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The FDA approval was based on data from a Phase 3 cUTI and a Phase 3 cIAI trial. In the cUTI trial, Zerbaxa achieved its primary endpoint of statistical non-inferiority vs. levofloxacin. The primary endpoint was a composite of microbiological eradication and clinical cure rate at 5-9 days after end of therapy. In the cIAI trial, Zerbaxa plus metronidazole, achieved the primary endpoint of statistical non-inferiority vs. meropenem. The primary endpoint was a clinical cure rate 24-32 days after treatment initiation.

Zerbaxa is the first antibiotic approved under the Generating Antibiotic Incentives Now (GAIN) Act to treat Gram-negative bacteria. It will be available as 1g/0.5g single-use vials in 10-count cartons.

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