The USFDA has recently approved a combination of imipenem, cilastatin and relebactam for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia. The approval was based on a clinical trial. The article focuses on the details of the drug, its approval, and the scientific evidence for the same.
Imipenem-cilastatin-relebactam is well-known for its efficacy in the treatment of complicated urinary tract and intra-abdominal infections in patients with limited or no alternative treatment options. However, the drug has recently been found efficacious in treating patients with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) . The safety and efficacy profiles of the drug were established in a randomized, controlled clinical trial based on which the FDA granted qualified infectious disease program, fast track, and priority…