The US Food and Drug Administration (FDA) has granted approval to United States-based Merck for its Recarbrio (imipenem, cilastatin and relebactam) intended to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI), it was reported yesterday.
The US FDA approved the product 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 company received the US FDA's qualified infectious disease product designation for the product to treat cUTI and cIAI, and received priority review designation for its new drug application for Recarbrio. According to the company, the approval of the three-drug combination injection is based on limited clinical safety and efficacy data.
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