Antibiotic Granted FDA Approval for Expanded Indication to Include Certain Pneumonia

Officials with the FDA have approved a combination of imipenem-cilastatin and relebactam (Recarbrio, Merck) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients aged 18 years and older, expanding the drug’s indication.

The combination of imipenem-cilastatin and relebactam was previously approved by the FDA to treat patients with complicated urinary tract infections and complicated intra-abdominal infections who have limited or no alternative treatment options.

HABP and VABP are a type of pneumonia that occurs in hospitalized patients and can cause symptoms that include fever, chills, cough, chest pain, and increased oxygen requirements. The combination drug is administered for treatment intravenously by a health care professional.

The safety and efficacy of the combination drug for the treatment of HABP/VABP were evaluated in a randomized, controlled clinical trial of 535 hospitalized adults with HABP/VABP due gram-negative bacteria. Of these patients, 266 were treated with imipenem-cilastatin and relebactam, and 269 patients were treated with piperacillin-tazobactam, another antibacterial drug. Overall, 16% of patients who received imipenem-cilastatin and relebactam, and 21% of patients who received piperacillin-tazobactam, died through day 28 of the study.

The most common adverse reactions observed in patients treated with imipenem-cilastatin and relebactam for HABP/VABP included increased liver enzymes, anemia, diarrhea, low potassium, and low sodium. Before initiating therapy with this combination drug, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams, and other allergens, according to the FDA. Imipenem-cilastatin and relebactam should not be used in patients who are prone to seizures and other central nervous system disorders. Clostridioides difficile-associated diarrhea has been reported with use of nearly all antibacterial agents, including imipenem-cilastatin and relebactam, and may range in severity from mild diarrhea to fatal colitis.

The application of imipenem-cilastatin and relebactam for HABP/VAPB was granted the FDA’s Qualified Infectious Disease Program (QIDP) designation. In addition, as part of QIDP designation, the FDA granted Fast Track and Priority Review designations to this application.

REFERENCE

FDA Approves Antibiotic to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia [news release]. Silver Spring, MD; June 4, 2020: FDA website. https://www.fda.gov/news-events/press-announcements/fda-approves-antibiotic-treat-hospital-acquired-bacterial-pneumonia-and-ventilator-associated Accessed June 5, 2020.