Merck & Co (MSD outside the United States and Canada) has announced that the pivotal Phase 3 clinical study evaluating the company’s antibiotic ZERBAXA® (ceftolozane and tazobactam) at an investigational dose for the treatment of adult patients with either ventilated hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) met the pre-specified primary endpoints.
In the U.S., ZERBAXA is currently indicated in adult patients for the treatment of complicated urinary tract infections, including pyelonephritis, caused by certain Gram-negative microorganisms, and is indicated, in combination with metronidazole, in adult patients for the treatment of complicated intra-abdominal infections caused by certain Gram-negative and Gram-positive microorganisms.
“HABP and VABP are serious and life-threatening hospital related pulmonary infections”
Based on these results, Merck plans to submit supplemental new drug applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking regulatory approval of ZERBAXA for this potential new indication. The company plans to submit results from the study for presentation at a future scientific conference.
Dr. Roy Baynes, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “HABP and VABP are serious and life-threatening hospital related pulmonary infections, especially in patients with severe underlying medical conditions. The results from the ASPECT-NP study demonstrate the potential role of ZERBAXA for the treatment of patients with HABP and VABP.”
This Phase 3 study assessed the safety and efficacy of ZERBAXA compared with meropenem in 726 adult patients diagnosed with either ventilated HABP or VABP requiring intravenous antibiotic therapy. In the study, ZERBAXA was administered in an investigational 3g dose compared with meropenem 1g, each given intravenously every eight hours for 8 to 14 days, or for 14 days for Pseudomonas aeruginosa infection. Meropenem is an approved broad-spectrum injectable antibiotic widely used to treat serious infections.