Merck to file sNDAs for Zerbaxa based on strong Phase III results

A pivotal Phase III clinical study evaluating the 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 USA, Zerbaxa, marketed by US pharma giant Merck & Co (NYSE: MRK), 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 US Food and Drug Administration and European Medicines Agency 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.