FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia
- by Team ABLE - 04 Jun, 2019
The U.S. Food and Drug Administration today approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older. The FDA granted the approval of Zerbaxa for the treatment of HABP/VABP to Merck & Co Inc.
The FDA initially approved Zerbaxain 2014to treat complicated intra-abdominal infections and for complicated urinary tract infections.
“A key global challenge we face as a public health agency is addressing the threat of antimicrobial-resistant infections,” said FDA Principal Deputy CommissionerAmy Abernethy. “Hospital-acquired and ventilator-associated bacterial pneumonia are serious infections that can result in death in some patients. New therapies to treat these infections are important to meet patient needs because of increasing antimicrobial resistance. That's why, among our other efforts to address antimicrobial resistance, we're focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections.”
HABP/VABP occur in patients in hospitals or other health care facilities and can be caused by a variety of bacteria. According to data from the U.S. Centers for Disease Control and Prevention, HABP and VABP are currently the second most common type of hospital-acquired infection in the United States, and are a significant issue in patients in the intensive care unit (ICU).
Zerbaxa received FDA'sQualified Infectious Disease Product(QIDP) designation for the treatment of HABP/VABP. The QIDP designation is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. As part of QIDP designation, the Zerbaxa marketing application for the HABP/VABP indication was grantedPriority Reviewunder which the FDA's goal is to take action on an application within an expedited time frame.
The FDA granted the approval of Zerbaxa for the treatment of HABP/VABP to Merck & Co Inc.