USFDA clears new anti-bacterial combo to treat UTIJuly 19, 2019
The US FDA has approved imipenem, cilastatin, and relebactam combo (Recarbrio) for injection, 1.25 grams to treat complicated urinary tract infections (cUTI).
Recarbrio is indicated in patients 18 years of age and older who have limited or no alternative treatment options, for cUTI, including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
The combination anti-bacterial is also indicated in patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated intra-abdominal infections (cIAI) caused by the following susceptible 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, Merck said.
Approval of these indications is based on limited clinical safety and efficacy data.
Relebactam received FDA’s Qualified Infectious Disease Product (QIDP) designation for the treatment of cUTI and cIAI. The New Drug Application (NDA) received Priority Review designation from the FDA.
Merck expects to make the drug available later this year.