Merck Submits NDA in China for Antibiotic Combination Ceftolozane/Tazobactam for Intra-abdominal Infections

On November 27, the CDE website showed that MSD's antibiotic compound "Ceflosulbactam Sodium for Injection" was submitted for marketing approval. Based on the clinical trial progress, it is speculated that the indication applied for this time is intra-abdominal infection.

This compound (development code: MK-7625A) was first approved for marketing in the United States in December 2014 under the trade name Zerbaxa. It is used in combination with metronidazole to treat complicated intra-abdominal infections and complicated urinary tract infections (including pyelonephritis) caused by designated susceptible microorganisms. Later, its indications were expanded to include hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP).

In August 2022, MSD published the results of the Phase III MK-7625A-015 study in China on the treatment of complicated intra-abdominal infections with ceftolozane-tazobactam sodium for injection in the International Journal of Infectious Diseases.

This study enrolled a total of 268 patients to evaluate the efficacy and safety of the compound (1500mg, three times daily) in combination with metronidazole (500mg, three times daily), compared with meropenem (1000mg, three times daily). The primary endpoint of the study was the clinical efficacy (clinical cure or clinical failure) at the test-of-cure (TOC) visit in the clinically evaluable (CE) population.

The results showed that the clinical cure rates of patients in the compound group and the meropenem group were 95.2% and 93.1%, respectively, meeting the non-inferiority criteria. In addition, regarding the secondary endpoint of microbiological response, the compound also demonstrated a therapeutic advantage (response rate 94.4% vs. 93.2%).

Source: International Journal of Infectious Diseases

MSD has been deeply engaged in the antibiotic field for many years, launching 22 antibiotic products, five of which are combination drugs.

Source: Nextpharma Database by PharmCube

The triple-combination compound "Betamethasone Dipropionate + Clotrimazole + Gentamicin" and the dual-combination compound "Imipenem + Cilastatin" have been launched in China. In July this year, another antibiotic triple-combination compound "Avycaz" by MSD also submitted an application for marketing authorization in China (see: ). Patients with bacterial infections can look forward to more treatment options.

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