An analysis of efficacy outcomes by causative pathogens showed that clinical and microbiologic response rates for Zerbaxa were comparable to meropenem for Gram-negative respiratory tract pathogens.
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During a presentation at a European medical conference, Merck & Company released late-stage data that showed that Zerbaxa (ceftolozane and tazobactam) was on par with meropenem as a treatment for adult patients with ventilated nosocomial (hospital-acquired) pneumonia.
Merck said the results from the Phase III ASPECT-NP trial has led the company to submit supplemental new drug applications to both the U.S. Food and Drug Administration and European Medicines Agency for approval in this indication. The FDA has set a PDUFA date of June 3 under priority, the company said. Merck presented detailed findings of the late-stage trial today at the 29th European Congress of Clinical Microbiology & Infectious Diseases.
Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia are life-threatening hospital-related pulmonary infections that can particularly impact patients who are already dealing with severe underlying medical conditions. There is a high mortality rate associated with these illnesses.
Merck initially reported the results of the Phase III trial in September, which set the stage for its potential approval for pneumonia patients. In the study, 726 patients were randomized 1:1 to receive an investigational 3g dose of Zerbaxa or 1g of meropenem, administered intravenously every eight hours for eight to 14 days. All of the patients in the trial were intubated and mechanically ventilated and nearly all were treated in the intensive care unit, Merck said.
Results from the ASPECT-NP trial showed that Zerbaxa was non-inferior to meropenem after 28 days in the intent to treat population. In the microbiologically evaluable (ME) population in patients with a Gram-negative pathogen at baseline, clinical cure rates were 75.2 percent and 66.7 percent for Zerbaxa and meropenem, respectively, Merck said. Also, microbiologic response rates were 69.9 percent and 62.4 percent for Zerbaxa and meropenem.
Results were consistent in the microbiologic intention-to-treat population with clinical cure rates of 73 percent and 67.9 percent for Zerbaxa and meropenem, respectively, the company said.
An analysis of efficacy outcomes by causative pathogens showed that clinical and microbiologic response rates for Zerbaxa were comparable to meropenem for Gram-negative respiratory tract pathogens.
Joan Butterton, associate vice president, infectious disease clinical research, Merck Research Laboratories, said there is an urgent need for treatment optioned in the intubated and mechanically ventilated patient population that was studied in ASPECT-NP. Butterton said Merck is “firmly committed to pursuing new treatment options for serious infectious diseases.”
At the time Merck filed its New Drug Application with the FDA in February, Nicholas Kartsonis, senior vice president, head of clinical research for infectious diseases and vaccines, Merck Research Laboratories, said there remains a “major unmet need” for new treatment options that can address the “growing danger of serious and potentially life-threatening infections caused by Gram-negative bacteria.” Kartsonis said Merck’s research and data underscore the company’s commitment to delivering new antibacterial agents to healthcare practitioners and patients.
Zerbaxa is an antibacterial combination product for intravenous infusion consisting of the cephalosporin antibacterial drug ceftolozane sulfate and the beta-lactamase inhibitor tazobactam sodium. Zerbaxa has already been approved in the United States for the treatment of adult patients with complicated urinary tract infections, including pyelonephritis, caused by certain susceptible Gram-negative microorganisms.
