The Food and Drug Administration (FDA) has approved Recarbrio™ (imipenem, cilastatin, and relebactam; Merck) for the treatment of patients 18 years of age and older with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (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.
The approval was based on data from the phase 3 RESTORE-IMI 2 trial, which included 535 patients who required treatment with intravenous antibiotic therapy for HABP or VABP. Patients were randomized to receive either Recarbrio 500mg/500mg/250mg (n=266) or piperacillin 4000mg/tazobactam 500mg (n=269) IV every 6 hours for 7-14 days. Both treatment arms also received open label empiric linezolid 600mg until baseline cultures confirmed absence of methicillin-resistant Staphylococcus aureus.
Results showed that Recarbrio was found to be noninferior to piperacillin/tazobactam; day 28 all-cause mortality (primary end point) was 15.9% vs 21.3%, respectively (adjusted treatment difference: -5.3%; 95% CI, -11.9 to 1.2). Additionally, 60.9% of patients treated with Recarbrio had a favorable clinical response at early follow-up (key secondary end point) vs 55.8% in the piperacillin/tazobactam arm (adjusted treatment difference: 5%; 95% CI, -3.2 to 13.2).
With regard to safety, the most common adverse reactions reported were elevated alanine aminotransferase and aspartate aminotransferase, anemia, diarrhea, hypokalemia and hyponatremia.
Recarbrio contains imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor. It is also indicated for the treatment of complicated urinary tract infections, including pyelonephritis, and complicated intraabdominal infections, in adult patients aged 18 years and older who have limited or no alternative treatment options.
The product is supplied in single-dose vials containing imipenem 500mg, cilastatin 500mg, and relebactam 250mg sterile powder for constitution.
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