FDA Approves Imipenem-Cilastatin and Relebactam for HABP/VABP

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

The indication follows a previous FDA approval for the Merck antibiotic combination in treating patients with complicated urinary tract infections and complicated intra-abdominal infections.

Recarbrio’s efficacy and safety in treating HABP/VABP was evidenced in a randomized, controlled trial involving 535 adults hospitalized with HABP/VABP due to gram-negative bacteria.

In the assessment, 266 patients were treated with therapy and 269 were treated with competitor therapy piperacillin-tazobactam. Investigators reported 16% of patients administered Recarbrio had died through day 28 of assessment—compared to 21% of patients on piperacillin-tazobactam.

The most common adverse events associated with imipenem-cilastatin and relebactam included increased liver enzymes, anemia, diarrhea, hypoalkemia, and hyponatremia.

The FDA advised that clinicians carefully inquire as to patient’s previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams and other allergens before initiating imipenem-cilastatin and relebactam for HABP/VABP.

The therapy’s application was previously granted Qualified Infectious Disease Program (QIDP) designation by the FDA, indicating it as a product intending to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act.

In a statement accompanying the approval, 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, emphasized the FDA’s role in facilitating new, effective, and safe therapies for antimicrobial-resistant infections.

“These efforts provide more options to fight serious bacterial infections and get new, safe and effective therapies to patients as soon as possible."