FDA approves Recarbrio in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.- Merck Inc
Merck Inc announced that 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 cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Pseudomonas 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.
The indication in HABP/VABP is based on results of the pivotal Phase III RESTORE-IMI 2 trial that compared Recarbrio 1.25 grams (imipenem 500 mg/cilastatin 500 mg/relebactam 250 mg) to piperacillin/tazobactam 4.5 grams (PIP/TAZ, piperacillin 4000 mg/tazobactam 500 mg), each administered intravenously every six hours for seven to 14 days, for the treatment of adult patients with HABP/VABP. Recarbrio met the primary and key secondary endpoints, demonstrating non-inferiority to PIP/TAZ in 28-day all-cause mortality and clinical response at early follow-up, respectively. The RESTORE-IMI 2 study abstract was published by the 30th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).