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FDA Approves Merck's Recarbrio for Complex Infections with Antimicrobial Stewardship Focus

• The FDA has granted approval for Recarbrio, Merck's novel triple-drug antibiotic combining imipenem/cilastatin with relebactam, for treating complicated urinary tract and intra-abdominal infections.

• Health authorities emphasize Recarbrio should be reserved as a last-resort treatment option, specifically for cases where limited or no alternative antibacterial drugs are available.

• The drug targets resistant gram-negative bacteria including Pseudomonas and Klebsiella species, with relebactam designed to overcome carbapenem resistance mechanisms.

Merck & Co has secured FDA approval for Recarbrio, a novel triple-drug antibiotic combination, though both the company and regulators emphasize its use should be limited to last-resort scenarios. This strategic approach aims to preserve the drug's effectiveness against resistant infections.
The newly approved treatment combines the established antibiotic duo imipenem/cilastatin with relebactam, Merck's innovative beta-lactamase inhibitor. The FDA has authorized its use in adults suffering from complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

Strategic Positioning as Last-Line Defense

"Recarbrio should be reserved for situations when there are limited or no alternative antibacterial drugs for treating a patient's infection," stated Ed Cox, director for the Office of Antimicrobial Products at the FDA, highlighting the importance of antimicrobial stewardship.
The development addresses a critical need in fighting antimicrobial resistance, particularly against carbapenem-resistant organisms. Relebactam's mechanism specifically targets and inhibits resistance pathways that have historically limited beta-lactam antibiotics' effectiveness, including carbapenems - traditionally considered last-line treatment options.

Spectrum of Activity

Recarbrio demonstrates effectiveness against several challenging Gram-negative pathogens, including:
  • Enterobacter cloacea
  • Escherichia coli
  • Klebsiella pneumoniae
  • Pseudomonas aeruginosa
For intra-abdominal infections, the drug's coverage extends to additional organisms, including various Bacteroides strains and other clinically significant pathogens like Citrobacter freundii and Fusobacterium nucleatum.

Commercial and Economic Implications

Despite its clinical significance, Recarbrio's market potential remains modest due to its positioning as a reserve treatment. Industry analysts, including Cowen & Co's Steve Scala, project sales of $50 million in 2020, growing to $150 million by 2024.
This limited commercial potential exemplifies the broader challenges facing antibiotic development. The situation has prompted innovative solutions, such as the UK's proposal for a new payment system that would compensate pharmaceutical companies based on the value their antibiotics provide to the healthcare system, rather than sales volume.

Global Health Impact

The approval comes amid growing concerns about antimicrobial resistance. A landmark 2016 review projected that without new antibiotics, drug-resistant infections could cause over 10 million deaths annually by 2050, with potential global economic impacts reaching $100 trillion.
Recarbrio's introduction represents a crucial addition to the antimicrobial arsenal, though its careful positioning reflects the delicate balance between providing necessary treatment options and preserving their effectiveness for future use.
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Reference News

[1]
Merck gets FDA nod for new antibiotic, but says use with care
pharmaphorum.com · Jul 17, 2019
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