FDA OKs Merck’s triplet antibiotic

The FDA approves Merck’s (NYSE:MRK) RECARBRIO (imipenem, cilastatin, relebactam) for injection, 1.25 gm for the treatment of patients at least 18 years old with complicated urinary tract infections, including pyelonephritis, and complicated intra-abdominal infections caused by certain Gram-negative bacteria who have limited or no alternative treatment options.

The agency reviewed the application under Qualified Infectious Disease Product and Priority Review status.

Imipenem is a penem antibacterial drug, cilastatin sodium is renal dehydropeptidase inhibitor and relebactam is a beta lactamase inhibitor. Cilastatin limits the renal metabolism of imipenem and has no antibacterial activity. Relebactam has no intrinsic antibacterial activity either but protects imipenem from degradation by certain beta lactamase enzymes.

Market launch should commence later this year.

https://seekingalpha.com/news/3478339-fda-oks-mercks-triplet-antibiotic

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