Zerbaxa Meets Primary Endpoints

Merck announced 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, demonstrating non-inferiority to meropenem, the active comparator, in Day 28 all-cause mortality and in clinical cure rate at the test-of-cure visit. 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.

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.

"HABP and VABP are serious and life-threatening hospital related pulmonary infections, especially in patients with severe underlying medical conditions," said Dr. Roy Baynes, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. "The results from the ASPECT-NP study demonstrate the potential role of Zerbaxa for the treatment of patients with HABP and VABP."

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