FDA approves combination therapy for complicated UTI

January 12, 2015

The FDA has approved ceftolozane/tazobactam (Zerbaxa) for the treatment of adults with complicated urinary tract infections.

The FDA has approved ceftolozane/tazobactam (Zerbaxa) for the treatment of adults with complicated urinary tract infections.

The agent, available in an intravenous formulation, combines a cephalosporin antibacterial drug (ceftolozane) and a beta-lactamase inhibitor (tazobactam). It is indicated for the treatment of complicated UTIs in adults, including pyelonephritis, caused by the following gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa. The approval also includes the treatment of complicated intra-abdominal infections caused by designated susceptible gram-negative bacteria.

ALSO READ: FDA committee recommends approval of complicated UTI agent

“The widespread prevalence of dangerous gram-negative pathogens together with their increased resistance to existing antibiotics has created a serious public health threat,” Louis B. Rice, MD, of the Warren Alpert Medical School of Brown University in Providence, RI, said in a news release from drug maker Cubist Pharmaceuticals, Inc. “Zerbaxa is a welcomed and much needed novel treatment for suspected or proven infections caused by susceptible gram-negative pathogens.”

The Infectious Diseases Society of America (IDSA), for which Dr. Rice serves as a member of the board of directors, said the approval “signifies several significant milestones in the battle against antibiotic-resistant superbugs.” It marks the halfway point in reaching the goal laid out by the IDSA’s 10 x ’20 Initiative, which calls for the development of 10 new systemic antibacterial drugs by 2020. In addition, ceftolozane/tazobactam is the first of the five 10 x ‘20 antibiotics to address certain serious and resistant gram-negative bacteria, the IDSA said in a statement.

“The new antibiotic will provide doctors more options for treating complicated urinary tract and complicated intra-abdominal infections,” the statement said. “But even this important approval doesn’t address all of our antibiotic needs. Patients still face life-threatening infections for which additional new antibiotics are urgently needed.”

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In a phase III complicated UTI trial, ceftolozane/tazobactam met its primary endpoint of statistical non-inferiority compared to levofloxacin (10% non-inferiority margin). The primary endpoint was a composite of microbiologic eradication and clinical cure rate (composite cure rate) at 5 to 9 days after end of therapy. The 95% confidence interval around the treatment difference had lower and upper bounds of 2.3% and 14.6%, respectively.

Ceftolozane/tazobactam is approved at a dose of 1.5 grams every 8 hours by intravenous infusion administered over 1 hour in patients 18 years or older with creatinine clearance (CrCl) >50 mL/min. Its label includes a warning about decreased efficacy seen in patients with renal impairment (baseline CrCl of 30 to ≤50 mL/min). CrCl should be monitored at least daily in patients with changing renal function and the dose adjusted accordingly.

The most common adverse events of the drug across trials included nausea, headache, and diarrhea.

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