The Food and Drug Administration (FDA) has accepted for review Merck‘s New Drug Applications (NDA) for 2 antibacterial agents. 

The first NDA is for the combination of relebactam, an investigational class A and C β-lactamase inhibitor, with imipenem/cilastatin (MK-7655A, IMI/REL) for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by certain susceptible Gram-negative bacteria in adults with limited or no alternative therapies available.

The second filing is for a supplemental NDA (sNDA) for Zerbaxa (ceftolozane and tazobactam) to treat adults with nosocomial pneumonia, including ventilator-associated pneumonia caused by certain susceptible Gram-negative microorganisms. Zerbaxa combines ceftolozane, a cephalosporin, and tazobactam, a β-lactamase inhibitor. It is already FDA approved to treat adults with cUTI (including pyelonephritis) caused by susceptible Gram-negative microorganisms; it is also indicated in combination with metronidazole to treat certain cIAIs caused by susceptible Gram-negative and Gram-positive microorganisms. 

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Both filings have been granted Priority Review by the Agency. The Prescription Drug User Fee Act (PDUFA) action date for IMI/REL is July 16, 2019, and for Zerbaxa, June 3, 2019. 

The IMI/REL NDA included data from the Phase 3 RESTORE-IMI 1 trial. The Zerbaxa sNDA included data from the Phase 3 ASPECT-NP trial. Full findings will be presented at a future scientific conference. 

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