Merck announced that the US FDA has approved the supplemental new drug application of Recarbrio (imipenem, cilastatin, and relebactam) for the treatment of hospital acquired and ventilator associated bacterial pneumonia.
HABP and VABP are common type of pneumonia that occurs in patients admitted in the hospitals.
The drug is approved for adult patients who are infected with either of the following: Acinetobacter calcoaceticus-baumanniicomplex, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Pseudomonas aeruginosa and Serratia marcescens.
The company has suggested the use of drug only in the susceptible species in order to prevent the development of resistance.
The approval is based on the pivotal Phase 3 RESTORE-IMI 2 trial in which the drug was compared with piperacillin/tazobactam 4.5 g. Both the drugs were administered intravenously every six hours for fourteen days. Recarbrio showed non-inferiority compared to piperacillin/tazobactam combination in terms of all-cause mortality. 28-day all cause mortality was 15.9% in Recarbrio arm compared to 21.3% in patients who were on piperacillin/tazobactam combination.
The drug is a combination product. Active ingredients are imipenem, a carbapenem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor. The drug has been earlier approved for complicated urinary tract infections (cUTI), including pyelonephritis, and complicated intra-abdominal infections (cIAI).