Merck: pneumonia drug meets late-stage trial goal
(CercleFinance.com) - Merck said a late-stage trial evaluating its antibiotic Zerbaxa has met the primary endpoint of being non-inferior to Pfizer's Meropenem in treating hospital-acquired bacterial pneumonia.
The US drugmaker said that a pivotal Phase 3 clinical study for the treatment of adult patients with either ventilated hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia met its primary endpoints, demonstrating non-inferiority to Meropenem, in all-cause mortality and in clinical cure rate.
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 for this potential new indication.
In the US, Zerbaxa is currently indicated for the treatment of urinary tract infections, and for the treatment of complicated intra-abdominal infections.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
The US drugmaker said that a pivotal Phase 3 clinical study for the treatment of adult patients with either ventilated hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia met its primary endpoints, demonstrating non-inferiority to Meropenem, in all-cause mortality and in clinical cure rate.
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 for this potential new indication.
In the US, Zerbaxa is currently indicated for the treatment of urinary tract infections, and for the treatment of complicated intra-abdominal infections.
Copyright (c) 2018 CercleFinance.com. All rights reserved.