MSD Submits New Drug Application in China for Antibiotic Combination Imipenem/Cilastatin/Relebactam (Recarbrio) for HABP/VABP

On July 12, MSD's antibiotic combination injection, Recarbrio (imipenem 500mg + cilastatin 500mg + relebactam 250mg), was submitted for marketing authorization in China. Based on the clinical trial progress, it is speculated that the indication for this submission is ventilator-associated bacterial pneumonia (VABP) and hospital-acquired bacterial pneumonia (HABP).

The active ingredients of Yaxiruilai contain three antibiotics with different mechanisms, among which Imipenem is a carbapenem antibiotic, Relebactam is a β-lactamase inhibitor, and Cilastatin is a dehydropeptidase inhibitor. In July 2019, Yaxiruilai was approved for the first time in the United States under the trade name Recarbrio, for the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal bacterial infections (cIAI) who have limited or no alternative treatment options. In June 2020, the indications for Yaxiruilai were expanded to include VABP and HABP.

Public information shows that MSD launched a global Phase III clinical trial (N=478) of Yasirui in the EU, Japan, and China in September 2018, evaluating the efficacy, safety, and tolerability of Yasirui compared to Tazocin (piperacillin + tazobactam, Pfizer) in treating HABP and VABP patients. The primary endpoint of the study was the all-cause mortality related to treatment on day 28. The study was completed in July 2022, with no relevant results disclosed so far.

The Phase III RESTORE-IMI 2 study conducted in the United States, the European Union, and Japan showed that imipenem/relebactam reduced all-cause mortality by 15.9% in patients with HABP and VABP, demonstrating non-inferiority to piperacillin/tazobactam (-21.3%).

HABP and VABP are both bacterial pneumonias that hospitalized patients are prone to. The former refers to pneumonia that newly occurs more than 48 hours after hospital admission in patients who have not received invasive mechanical ventilation and are not in the incubation period of pathogen infection during their hospital stay. The latter refers to pneumonia that occurs more than 48 hours after patients with tracheal intubation or tracheostomy receive mechanical ventilation, or pneumonia that appears within 48 hours after weaning from mechanical ventilation or extubation. Both can cause symptoms such as fever, chills, cough, chest pain, and increased oxygen demand.

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