Merck’s sNDA for RECARBRIO Wins FDA Approval

Merck received approval from the FDA for its 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 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 additional indication in HABP/VABP is based on results from a Phase III RESTORE-IMI 2 trial that compared RECARBRIO to piperacillin/tazobactam 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.

RECARBRIO is also indicated in adults who have limited or no alternative treatment options for complicated urinary tract infections (cUTI), including pyelonephritis, and complicated intra-abdominal infections (cIAI) caused by susceptible Gram-negative bacteria, as described below. RECARBRIO is administered via intravenous injection.