Regulatory Review Filings for 2 Antibacterial Agents Accepted by FDA

A New Drug Application (NDA) and a supplemental NDA (sNDA) were accepted for the Priority Review for products being developed by Merck.

Regulatory filings for 2 antibacterial agents being developed by Merck have been accepted for review by the FDA.

A New Drug Application (NDA) was accepted for the Priority Review of the combination of relebactam with imipenem/cilastatin for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by susceptible gram-negative bacteria in adults with limited or no alternative therapies available.

A supplemental NDA (sNDA) was accepted for the Priority Review of ceftolozane/tazobactam (ZERBAXA) to treat adult patients with nosocomial pneumonia, including ventilator-associated pneumonia caused by particular susceptible gram-negative microorganisms including Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, and Streptococcus salivarius.

“There is a major unmet need for new treatment options to address the growing danger of serious and potentially life-threatening infections caused by Gram-negative bacteria,” Nicholas Kartsonis, MD, senior vice president and head of clinical research for infectious diseases and vaccines with Merck Research Laboratories, said in a prepared statement.

In the United States, ceftolozane/tazobactam is currently approved for the treatment of adult patients with cUTI, including pyelonephritis, caused by particular gram-negative microorganisms, as well as in combination with metronidazole for the treatment of cIAI caused by susceptible gram-negative and gram-positive microorganisms in adult patients.

The NDA for imipenem/cilastatin/relebactam was based on the results of the phase 3 RESTORE-IMI1 trial. Relebactam is an investigational, intravenous, class A and C beta-lactamase inhibitor.

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