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FDA Approves Merck’s RECARBRIO (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)

FDA Approves Merck’s RECARBRIO (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)

The FDA has approved a supplemental New Drug Application (sNDA) for RECARBRIO™ (imipenem, cilastatin, and relebactam) for the treatment of patients 18 years of age and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacaeEscherichia coliHaemophilus influenzaeKlebsiella aerogenesKlebsiella oxytocaKlebsiella pneumoniaePseudomonas aeruginosa and Serratia marcescens. To reduce the development of drug-resistant bacteria and maintain the effectiveness of RECARBRIO and other antibacterial drugs, RECARBRIO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity to any component of RECARBRIO. See Selected Safety Information below.

“Hospital-acquired infections continue to be a significant cause of illness and death despite advances in our understanding of the contributing factors and prevention of these diseases,” said Dr. Keith Kaye, professor of medicine and director of research for the division of infectious diseases, University of Michigan Health System, and a principal investigator in the clinical program. “Because these infections are often caused by difficult to treat Gram-negative organisms, new therapeutic options such as RECARBRIO are urgently needed for patients.”

RECARBRIO is a combination of imipenem, a carbapenem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor. Relebactam protects imipenem from degradation by certain serine beta-lactamases such as SHV (Sulfhydryl Variable), TEM (Temoneira), CTX-M (Cefotaximase-Munich), P99 (Enterobacter cloacae P99), PDC (Pseudomonas-derived cephalosporinase), and KPC (Klebsiella-pneumoniae carbapenemase).

“At a time of great public health concern about the need for new treatments to meet the evolving challenges posed by Gram-negative bacteria, we are proud to continue bringing new therapeutic options to health care practitioners in an effort to help them overcome the challenges in patient care,” said Dr. Nicholas Kartsonis, senior vice president, clinical research, infectious diseases and vaccines, Merck Research Laboratories. “Today’s approval is further affirmation of Merck’s steadfast commitment to meeting the needs of the health care community.”

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