- The approval is based on P-III ASPECT-NP study results assessing Zerbaxa (3gm, IV every 8hrs.) vs meropenem (1gm, IV, every 8hrs.) in 726 patients with HABP/VABP on mechanical ventilation aged ≥18yrs.
- The P-III ASPECT-NP study results demonstrated that Zerbaxa is superior to meropenem for 28-day all-cause mortality (24% vs 25.3%), clinical response at Test-of-Cure (54.4% vs 53.3%)
- Zerbaxa is a combination therapy of anti-bacterial & beta-lactamase inhibitor, act by reducing the development of drug-resistant bacteria and has received FDA’s Priority Review designation for preventing infection by susceptible Gram-negative microorganisms
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