The FDA has approved Recarbrio (imipenem-cilastatin and relebactam), from Merck & Co. Inc., of Kenilworth, N.J., to treat adults with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).
The approval was based on results of a randomized trial of 535 hospitalized adults with HABP/VABP due to gram-negative bacteria, with 266 treated with Recarbrio and 269 treated with piperacillin/tazobactam. Data from the Restore-Imi 2 trial showed Recarbrio demonstrated noninferiority vs. piperacillin/tazobactam in primary and key secondary endpoints of 28-day all-cause mortality and clinical response, respectively. Sixteen percent of patients receiving Recarbrio and 21% receiving piperacillin/tazobactam died through day 28 of the study. Results were posted among study abstracts by the 30th European Congress of Clinical Microbiology & Infectious Diseases.
The sNDA for treating infections caused by susceptible gram-negative microorganisms was granted priority review and in February. Its PDUFA date was today, June 4. The application received a qualified infectious disease program designation.
In December, the EMA's Committee for Medicinal Products for Human Use adopted a positive opinion recommending the combination antibacterial agent for approval for treating gram-negative bacterium infection in adults.
On July 17, 2019, based on a priority review designation, the FDA approved the same combination of Recarbrio (imipenem-cilastatin and relebactam) as a 1.25-g injection for adults with limited or no alternatives for treating complicated urinary tract infections (cUTIs), including pyelonephritis caused by the gram-negative microorganisms Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae and Pseudomonas aeruginosa.
It was also approved for treating for adults with limited or no alternatives for complicated intra-abdominal infections (cIAIs) caused by gram-negative microorganisms Bacteroides caccae, Bacteroides fragilis, Bacteroides ovatus, Bacteroides stercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Fusobacterium nucleatum, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Parabacteroides distasonis and Pseudomonas aeruginosa.
The latest Recarbrio approval was supported in part by efficacy and safety findings of imipenem-cilastatin to treat cUTI and cIAI. The combination was assessed with data from in vitro studies and animal models of infection as well as safety data from separate trials for cUTI and cIAI.