The FDA has approved Recarbrio to treat patients 18 years of age and older who have limited or no alternative treatment options for cUTI, including pyelonephritis, caused by susceptible Gram-negative microorganisms such as Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
It is also approved to treat adult patients with cIAI caused by susceptible Gram-negative microorganisms such as 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 FDA’s Centre for Drug Evaluation and Research antimicrobial products office director Dr Ed Cox said: “The FDA remains focused on facilitating the development of safe and effective new antibacterial drugs to give patients more options to fight serious infections.
“It is important that the use of Recarbrio be reserved for situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection.”
Merck secured FDA’s qualified infectious disease product (QIDP) designation for Relebactam to treat cUTI and cIAI, as well as received priority review designation for its new drug application (NDA) for Recarbrio.
According to the company, the approval of the three-drug combination injection is based on limited clinical safety and efficacy data.
Imipenem is a penem antibacterial drug, while cilastatin sodium is a renal dehydropeptidase inhibitor and relebactam is a beta lactamase inhibitor.
Cilastatin minimises the renal metabolism of imipenem and does not have antibacterial activity, while relebactam protects imipenem from degradation by certain serine beta lactamases such as Sulhydryl Variable (SHV), Temoneira (TEM), Cefotaximase-Munich (CTX-M), Enterobacter cloacae P99 (P99), Pseudomonas-derived cephalosporinase (PDC), and Klebsiella-pneumoniae carbapenemase (KPC).
Merck Research Laboratories infectious diseases and vaccines senior vice president Dr Nick Kartsonis said: “Today’s announcement is a great example of Merck’s longstanding commitment to infectious diseases research and development, as we continue to search for novel ways to approach difficult-to-treat pathogens.”