Merck's Novel Antibiotic Recarbrio Receives FDA Approval for Complicated Urinary Tract and Intra-Abdominal Infections

On July 18, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media that Merck & Co. announced its novel antibiotic Recarbrio had received FDA approval for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). To reduce bacterial resistance and ensure the efficacy of Recarbrio and other antimicrobial agents, Recarbrio is approved only for the treatment or prevention of confirmed infections caused by susceptible bacteria. Merck & Co. expects to launch Recarbrio later this year.

Recarbrio is a combination of imipenem, cilastatin, and relebactam. Imipenem is a carbapenem antibiotic, cilastatin is a renal dehydropeptidase inhibitor, and relebactam is a beta-lactamase inhibitor. Cilastatin inhibits the renal metabolism of imipenem and lacks antibacterial activity.

Imipenem binds to PBP 2 and PBP 1B in Enterobacteriaceae and Pseudomonas aeruginosa, thereby inhibiting penicillin-binding proteins (PBPs); this inhibition disrupts bacterial cell wall synthesis.

Relebactam has no intrinsic antibacterial activity, but it protects imipenem from degradation by certain serine β-lactamases, such as sulfhydryl variable (SHV), temoneira (TEM), cefotaximase (CTX-M), Enterobacter cloacae P99 (P99), Pseudomonas-derived cephalosporinase (PDC), and Klebsiella pneumoniae carbapenemase (KPC).

Patients with a history of severe hypersensitivity are strictly prohibited from using any component of Recarbrio. Overdose of imipenem (a component of Recarbrio) may cause adverse reactions such as seizures, confusion, and muscle spasms, which are most common in patients with brain injury or impaired renal function. Concurrent use of Recarbrio with valproic acid or divalproex sodium may increase the risk of seizures.

“Recarbrio provides an important addition to our toolkit in the fight against infections caused by certain Gram-negative pathogens,” said Dr. Keith Kaye, Professor of Medicine and Director of Research in the Division of Infectious Diseases at the University of Michigan Health System, and principal investigator of the clinical program. “In certain cases, treatment options for these patients are limited, and Recarbrio offers an additional therapeutic option for patients with cIAI and cUTI.”

Dr. Nick Kartsonis, Senior Vice President of Infectious Diseases and Vaccines at Merck Research Laboratories, stated, “The FDA’s approval is a strong testament to Merck’s long-standing commitment to infectious disease research and development, and we will continue to seek new approaches for treating pathogens.”

Merck, founded in 1891 and headquartered in Whitehouse Station, New Jersey, USA, is one of the world’s largest pharmaceutical companies and a globally recognized leader in healthcare. The Group primarily focuses on innovative pharmaceuticals, life sciences, and cutting-edge functional materials technologies.

Merck is always driven by technology, creating value for patients and customers. Merck’s business is primarily divided into four branches: the Merck Serono business branch, the Consumer Health business branch, the MilliporeSigma business branch, and the Performance Materials business branch.

(Compiled by Cheng Tao)