Phase III results for Zerbaxa (ceftolozane/tazobactam) in cUTI and cIAI published in The Lancet and Clinical Infectious Diseases- Merck Inc

Merck Inc. has announced that The Lancet and Clinical Infectious Diseases have published online the results from the pivotal Phase III clinical studies of Zerbaxa (ceftolozane/tazobactam) for Injection (1 g/0.5 g) in complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI), respectively. Both studies met their primary endpoints.

Zerbaxa met the cUTI study’s primary endpoint of statistical non-inferiority compared to levofloxacin (10% non-inferiority margin). The primary endpoint was a composite of microbiological eradication and clinical cure rate (composite cure rate) at 5-9 days after the end of therapy (the test of cure visit). In the second study, treatment with Zerbaxa plus metronidazole was shown to be effective in patients with cIAI, including those infections caused by certain resistant pathogens, such as extended-spectrum beta-lactamase (ESBL) producing Enterobacteriacae. Results of the secondary analyses for the studies were consistent with and supportive of the primary outcomes.

Comment: Zerbaxa is the first new antibiotic approved in the U.S. under the Generating Antibiotic Incentives Now (GAIN) Act to treat Gram-negative bacteria. Zerbaxa is designated by the FDA as a Qualified Infectious Disease Product for its indications, according to the GAIN Act. The GAIN Act provides incentives to develop new antibacterial drugs for the treatment of serious or life-threatening disease or condition caused by drug resistant pathogens.