FDA indicated Recarbrio for patients aged 18 years or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP)
The US FDA Center for Drug Evaluation and Research main entrance. (Credit: The U.S. Food and Drug Administration/Wikipedia.)
Merck has received the US Food and Drug Administration (FDA) approval for Recarbrio (imipenem, cilastatin, and relebactam) supplemental New Drug Application (sNDA).
Recarbrio has been indicated for patients aged 18 years or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by specific susceptible Gram-negative microbes.
The Gram-negative microbes include Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Pseudomonas aeruginosa and Serratia marcescens.
Merck Research Laboratories infectious diseases and vaccines clinical research senior vice president Nicholas Kartsonis said: “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.
“Today’s approval is further affirmation of Merck’s steadfast commitment to meeting the needs of the health care community.”
Merck designed Recarbrio as a combination of imipenem, cilastatin, and relebactam
Recarbrio is a combination of three compounds including imipenem, a carbapenem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor.
Relebactam is said to protect imipenem from the effect of certain serine beta-lactamases including as Sulfhydryl Variable (SHV), Temoneira, Cefotaximase-Munich (CTX-M), Enterobacter cloacae P99, Pseudomonas-derived cephalosporinase (PDC), and Klebsiella-pneumoniae carbapenemase (KPC).
The drug is advised only to treat or prevent infections that are believed to be caused by susceptible bacteria, to reduce the development of drug-resistant bacteria and maintain the antibacterial activity.
In addition, Recarbrio is contraindicated in patients with a history of known severe hypersensitivity to any component of Recarbrio. See Selected Safety Information below.
The FDA approval for the additional indication is based on results of the Phase 3 RESTORE-IMI 2 clinical trial, which evaluated Recarbrio compared to piperacillin/tazobactam for the treatment of adult patients with HABP/VABP.
In the clinical study, Recarbrio has reached the primary and key secondary endpoints, showing non-inferiority to PIP/TAZ in 28-day all-cause mortality and clinical response at early follow-up.
Principal investigator in the clinical program Keith Kaye said: “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.
“Because these infections are often caused by difficult to treat Gram-negative organisms, new therapeutic options such as Recarbrio are urgently needed for patients.”