Merck, known as MSD outside the United States and Canada, today announced the first presentation of results from ASPECT-NP, a randomized, double-blind, multi-center Phase 3 clinical trial evaluating the efficacy and safety of ZERBAXA® (ceftolozane and tazobactam) for the treatment of adult patients with ventilated nosocomial (hospital acquired) pneumonia.
The results demonstrated non-inferiority of an investigational dose of ZERBAXA to meropenem, the active comparator, in the primary and key secondary endpoints. Based on these results, Merck has submitted supplemental new drug applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking regulatory approval for ZERBAXAP for this potential new indication. The FDA Prescription Drug User Fee Act (PDUFA) date is June 3, 2019. Detailed findings of the ASPECT-NP Phase 3 trial are scheduled to be presented at the 29thEuropean Congress of Clinical Microbiology & Infectious Diseases (ECCMID), on Monday, April 15 at 1:30 pm local time in Amsterdam, Netherlands.
“ASPECT-NP is unique among registration trials for nosocomial pneumonia, as all patients were intubated and mechanically ventilated and nearly all were treated in the intensive care unit,”
said Dr. Marin Kollef, director of Medical Critical Care and Respiratory Care Services of Barnes-Jewish Hospital and the Golman Professor of Medicine at Washington University School of Medicine, St. Louis, MO.
“This is a disease state with a high mortality rate, and Merck’s commitment to this trial provides meaningful evidence that helps expand our understanding of the management of this patient population.”
In the U.S., ZERBAXA is currently indicated for the treatment of adult patients with complicated urinary tract infections, including pyelonephritis, caused by certain susceptible Gram-negative microorganisms, and is indicated, in combination with metronidazole, for the treatment of adult patients with complicated intra-abdominal infections caused by certain susceptible Gram-negative and Gram-positive microorganisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.