Recently, the US FDA announced that it has approved the expansion of the innovative antibiotic Recarbrio developed by Merck & Co. (MSD) to treat patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) over 18 years of age. Recarbrio was previously approved by the FDA for the treatment of patients with complicated urinary tract infections and complicated intra-abdominal infections.
HABP/VABP is a type of pneumonia that occurs in hospitalized patients and can cause fever, chills, cough, chest pain, and increased oxygen demand. Due to the excessive use of antibiotics, many bacteria that cause HABP and VABP are resistant to existing antibiotics. Therefore, patients need new antibiotics to control bacterial infections.
Recarbrio is a compound preparation of imipenem, cilastatin and relebactam. Relebactam is a diazabicyclooctane β-lactamase inhibitor with broad-spectrum anti-β lactamase activity. Although the β-lactamase inhibitor itself has no antibiotic activity, it can enhance the activity of β-lactam antibiotics. Recarbrio has obtained the Qualified Infectious Disease Product (QIDP), Fast Track and Priority Review qualification granted by the FDA.
The safety and effectiveness of Recarbrio in the treatment of HABP/VABP was tested in a randomized controlled clinical trial involving 535 HABP/VABP hospitalized adult patients due to Gram-negative bacterial infections. In this trial, 266 patients were treated with Recarbrio and 269 patients were treated with piperacillin + tazobactam. Within 28 days of treatment, 16% of patients receiving Recarbrio died, and the mortality rate of patients receiving piperacillin + tazobactam was 21%.
"As a public health agency, FDA addresses the threat of antibiotic-resistant infections by promoting the development of safe and effective new treatments," said Dr. Sumathi Nambiar, director of the Anti-Infectives Division of the Office of Infectious Diseases, FDA Center for Drug Evaluation and Research. "These efforts Provide more options to fight serious bacterial infections, and let patients get safe and effective new treatments as soon as possible."