On February 5, Merck announced that FDA has accepted two new antibiotic drug applications and granted priority review.Includes:
1) Relebactam in Combination with Imipenem/Cilastatin (MK-7655A, IMI/REL) for the Treatment of Complicated Urinary Tract Infections (cUTI) and Complicated Intra-abdominal Infections (cIAI) in Adults Suspected to be Caused by Gram-negative Bacteria with a PDUFA Scheduled Approval Period of 16 July 2019.
2) Zerbaxa (Ceftolozane/Tazobactam) Supplemental New Drug Application for the Treatment of Hospital-Acquired Pneumonia in Adults, PDUFA scheduled approval date is June 3, 2019.The marketing application for
IMI/REL (MK-7655A) is primarily based on the results of the pivotal phase 3 RESTORE-IMI 1 study; Zerbaxa's sNDA is primarily based on the results of the pivotal phase 3 ASPECT-NP study.Merck also submitted two new drug applications to EMA, which are currently under review.
Relebactam is a class A (ultra-broad beta-lactamase and KPC) and a class C (AmpC enzyme) broad-spectrum beta-lactamase inhibitor for intravenous injection, and Relebactam in combination with IMI/REL for specific Gram-negative infections by the FDA Qualified infectious disease product (QIDP) qualification, as well as treatment of complex urinary tract infections. Hospital acquired pneumonia. Fast-track qualification for ventilator-associated pneumonia.
Zerbaxa is currently approved in the United States for the treatment of adult complicated urinary tract infections caused by specific Gram-negative bacteria. Pyelonephritis, and combined with metronidazole for the treatment of adult complicated intra-abdominal infections caused by specific Gram-negative or Gram-positive bacteria.