Merck confirms FDA approval of Zerbaxa indication
Merck announced that the U.S. Food and Drug Administration has approved Merck's supplemental New Drug Application for the use of ZERBAXA for the treatment of patients 18 years and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Serratia marcescens. The sNDA for ZERBAXA had previously been designated Priority Review status by the FDA. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. This expanded use is based on results of the pivotal Phase 3 ASPECT-NP trial that compared ZERBAXA 3g intravenously every 8 hours to meropenem for 8 to 14 days for the treatment of adult patients with HABP/VABP. "We are grateful to all of the patients who participated in the studies which led to the approval of ZERBAXA for the treatment of HABP/VABP," said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. "This approval reflects Merck's longstanding commitment to helping alleviate the burden of infectious diseases, including serious infections caused by Gram-negative pathogens."