in people aged 18 years and older.
Approval for Recarbrio was based on results of a randomized, controlled clinical trial of 535 hospitalized adults with hospital-acquired and ventilator-associated bacterial pneumonia who received either Recarbrio or piperacillin-tazobactam. After 28 days, 16% of patients who received Recarbrio and 21% of patients who received piperacillin-tazobactam had died.
The most common adverse events associated with Recarbrio are increased alanine aminotransferase/ aspartate aminotransferase, anemia, diarrhea, hypokalemia, and hyponatremia. Recarbrio 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, according to an FDA press release.
“As a public health agency, the FDA addresses the threat of antimicrobial-resistant infections by facilitating the development of safe and effective new treatments. These efforts provide more options to fight serious bacterial infections and get new, safe and effective therapies to patients as soon as possible,” said Sumathi Nambiar, MD, MPH, director of the division of anti-infectives within the office of infectious disease at the Center for Drug Evaluation and Research.