MSD's Antibiotic Combination Therapy Zerbaxa (Ceftolozane/Tazobactam) Approved in China for Complicated Infections

Feb 11, 2025 15:43 CST Updated 15:43

MSD

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Today (February 11), the latest announcement on the official website of China's National Medical Products Administration (NMPA) stated,The 5.1 class new drug applied by MSDCefalosporin Sodium for InjectionThe marketing application has been approved.According to the data, this is a compound antibacterial drug (brand name Zerbaxa), which containsCephalosporin antibioticsCeftolozaneβ-Lactamase InhibitorTazobactam. MSD has previously completed a Phase 3 clinical study in China to evaluate the product's treatment.Complicated Intra-abdominal InfectionsEfficacy and safety.

Screenshot Source: NMPA official website

Zerbaxa is an antibiotic combination product. This product was originally developed by Cubist Pharmaceuticals and acquired by Merck & Co., Inc. (MSD) in 2014 for approximately $9.5 billion in cash, bringing this product under its umbrella. The product was subsequentlyApproved by the U.S. FDA in 2014 for the treatment of infections caused by certain Gram-negative bacteriaComplicated Urinary Tract Infection, and combined treatment with metronidazoleComplicated Intra-abdominal Infections. In June 2019, the FDA announcedApprovalThis product treatsHospital-Acquired/Bacteremia-Associated Bacterial Pneumonia (HABP/VABP)。

August 2022,Int J Infect DisThe journal published the results of a Phase 3 clinical study aimed at evaluating Zerbaxa plus metronidazole versus meropenem for treatment.Chinese PatientsComplicated Intra-abdominal Infections（cIAI）The efficacy and safety were primarily evaluated based on the clinical response rate in the Test-Of-Cure (TOC). The results showed that the clinical response rates for patients treated with Zerbaxa plus metronidazole and those treated with meropenem were...The clinical cure rates were 95.2% and 93.1%, respectively., meeting the non-inferiority criteria. The researchers concluded that in Chinese adult patients with cIAI, Zerbaxa plus metronidazole is as effective as meropenem and has a comparable safety profile.

Complicated Intra-abdominal Infections (cIAI) are hospital-acquired or community-acquired infections, caused by the extension of hollow organ infections into the peritoneal cavity, leading to peritonitis or abscesses. cIAI includes intra-abdominal abscesses, gastric or intestinal perforation, peritonitis, appendicitis, cholecystitis, and diverticulitis, among others. cIAI is caused by various pathogens, including Gram-negative bacteria, Gram-positive bacteria, and anaerobic bacteria.

We hope that the approval of MSD's antibacterial combination therapy will benefit more patients as soon as possible.

References:

[1] Drug Approval Certificate Delivery Information on February 11, 2025 From https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250211152345189.html

[2] Breaking News | MSD Announces $9.5 Billion Acquisition of Antibiotics Giant Cubist Pharmaceuticals to Strengthen In-Hospital Acute Care Treatment Capabilities. Retrieved Dec 09, 2014. From https://mp.weixin.qq.com/s/Estm7s9TSc_BzSFhKoK5zA

[3]ClinicalTrials Official Website. From https://clinicaltrials.gov/study/NCT03830333

[4]Yihong Sun et al .(2022) A phase III, multicenter, double-blind, randomized clinical trial to evaluate the efficacy and safety of ceftolozane/tazobactam plus metronidazole versus meropenem in Chinese participants with complicated intra-abdominal infections.Int J Infect Dis. DOI: 10.1016/j.ijid.2022.08.003

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