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The agency welcomes another option for serious bacterial infections.
FDA cleared imipenem-cilastatin and relebactam (Recarbrio, Merck)
to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years 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. The drug is administered intravenously by a healthcare professional.
“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, MD, MPH, director of the Division of Anti-Infectives within the Office of Infectious Disease in FDA’s Center for Drug Evaluation and Research. In a 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.”
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 in which 266 patients were treated with Recarbrio and 269 patients were treated with piperacillin-tazobactam (Tazocin, other brand names), another antibacterial drug.
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Overall, 16% of patients who received Recarbrio 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 Recarbrio for HABP/VABP included increased aspartate/alanine aminotransferases (increased liver enzymes), anemia, diarrhea, hypokalemia (low potassium) and hyponatremia (low sodium).