EMA Panel Endorses Antibacterial Drug Trio Recarbrio

Megan Brooks

December 16, 2019

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the antibacterial drug trio imipenem, cilastatin, and relebactam (Recarbrio, Merck Sharp & Dohme) for the treatment of infections due to aerobic Gram-negative organisms in adults with "limited" treatment options.

Recarbrio combines a carbapenem antibacterial agent that inhibits the formation of peptidoglycan (a key component of the bacterial cell wall); a renal dehydropeptidase inhibitor that limits renal metabolism of the carbapenem; and a novel beta-lactamase inhibitor that prevents certain classes of beta-lactamases (classes A and C, but not classes B and D) from hydrolysing the carbapenem, thereby restoring its antibacterial activity against certain resistant bacteria, the panel explains in a summary statement.

Recarbrio has the ability to effectively treat susceptible infections, the panel concluded. The most common side effect is diarrhea.

Once approved, Recarbrio will be available as a 500 mg/500 mg/250 mg powder for solution for infusion.

Recarbrio should be prescribed "only after consultation with a physician with appropriate experience in the management of infectious diseases," the panel said.

The summary of product characteristics will include detailed recommendations for use of Recarbrio and will be published in the European public assessment report, which will be made available in all official European Union languages after the European Commission grants marketing authorization.

The US Food and Drug Administration approved Recarbrio last summer for complicated urinary tract infection (cUTI) and complicated intra-abdominal infection (cIAI) in adults for whom limited or no treatment options are available, as reported by Medscape Medical News.

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