FDA Expands Use for Antibiotic

The US Food and Drug Administration (FDA) has approved a combination of imipenem-cilastatin and relebactam (Recarbrio) for the treatment of patients aged 18 or older with hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia (HABP/VABP).

The therapy had already been FDA-approved for the treatment of patients with complicated urinary tract infections and complicated intraabdominal infections who have limited or no alternative treatment options. 

The new approval comes after the imipenem-cilastatin and relebactam combination was shown to be safe and effective in a randomized, controlled clinical trial that comprised 535 hospitalized adults with HABP/VABP due to gram-negative bacteria.

The most common adverse reactions among patients treated with the imipenem-cilastatin and relebactam combination for HABP/VABP—which is administered intravenously—were increased aspartate/alanine aminotransferases, anemia, diarrhea, hypokalemia, and hyponatremia.

“As a public health agency, the FDA addresses the threat of antimicrobial-resistant infections by facilitating the development of safe and effective new treatments,” Sumathi Nambiar, MD, MPH, director of the Division of Anti-Infectives within the Office of Infectious Disease in FDA’s Center for Drug Evaluation and Research, said in the FDA press release. “These efforts provide more options to fight serious bacterial infections and get new, safe and effective therapies to patients as soon as possible.”

—Colleen Murphy

Reference:

FDA approves antibiotic to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. News release. US Food and Drug Administration. June 4, 2020. Accessed June 5, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-antibiotic-treat-hospital-acquired-bacterial-pneumonia-and-ventilator-associated