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Source:

Press Release

Disclosures: Nambiar is the director of the division of anti-infectives in the Office of Infectious Disease in FDA’s Center for Drug Evaluation and Research.
June 05, 2020
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FDA approves Recarbrio for hospital-acquired bacterial pneumonia

Source/Disclosures
Source:

Press Release

Disclosures: Nambiar is the director of the division of anti-infectives in the Office of Infectious Disease in FDA’s Center for Drug Evaluation and Research.
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The FDA approved Merck’s Recarbrio today, a three-drug combination antibiotic injection for the treatment of hospital-acquired bacterial pneumonia, or HABP, and ventilator-associated bacterial pneumonia, or VABP, in patients aged 18 years and older, according to a press release from the FDA.

Recarbrio, which contains imipenem/cilastatin and relebactam, was previously approved to treat complicated UTIs and intra-abdominal infections in July 2019.

ventilated patient
Source: Adobe Stock

“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 in the Office of Infectious Disease in FDA’s Center for Drug Evaluation and Research, said 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.”

Researchers evaluated the efficacy and safety of Recarbrio in a randomized controlled trial of 535 hospitalized adults with HABP/VABP due to gram-negative bacteria in which 266 were given Recarbrio and 269 were given piperacillin-tazobactam. Results showed that 16% of the patients given Recarbrio and 21% of patients given piperacillin-tazobactam died through day 28 of the study.

Common adverse reactions in patients treated with Recarbrio included increased liver enzymes, diarrhea, anemia, hypokalemia and hyponatremia. Clostridioides difficile-associated diarrhea has occurred with nearly all antibacterial agents, including Recarbrio, and may range in severity from mild diarrhea to fatal colitis, according to the release.

The FDA emphasized that patients should be evaluated for prior hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta-lactam agents and other allergens before starting Recarbrio. The agency also noted that Recarbrio should not be used in patients who are prone to seizures and other central nervous system disorders.