- For Immediate Release:
On June 5, 2020 this press release was updated with information on the data that supported its approval for this indication.
Today, the U.S. Food and Drug Administration approved Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years of age and older. Recarbrio was previously FDA-approved to treat patients with complicated urinary tract infections and complicated intra-abdominal infections who have limited or no alternative treatment options.
“As a public health agency, the FDA addresses the threat of antimicrobial-resistant infections by facilitating the development of safe and effective new treatments,” said Sumathi Nambiar, M.D., M.P.H., director of the Division of Anti-Infectives within the Office of Infectious Disease in FDA’s Center for Drug Evaluation and Research. “These efforts provide more options to fight serious bacterial infections and get new, safe and effective therapies to patients as soon as possible.”
HABP and VABP are a type of pneumonia that occurs in hospitalized patients and can cause symptoms such as fever, chills, cough, chest pain and increased oxygen requirements. Recarbrio is a combination of imipenem-cilastatin and relebactam. The drug is administered intravenously by a health care professional.
The safety and efficacy of Recarbrio 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 (a type of bacteria) in which 266 patients were treated with Recarbrio and 269 patients were treated with piperacillin-tazobactam, another antibacterial drug. Overall, 16% of patients who received Recarbrio and 21% of patients who received piperacillin-tazobactam died through Day 28 of the study.