FDA Approves Merck's Recarbrio for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia

Today, the U.S. FDA announced the approval of an expanded indication for Recarbrio, an innovative antibiotic developed by MSD, for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients aged 18 years and older. Recarbrio had previously received FDA approval for the treatment of patients with complicated urinary tract infections and complicated intra-abdominal infections.

HABP/VABP is a type of pneumonia that predominantly occurs in hospitalized patients and can cause symptoms such as fever, chills, cough, chest pain, and increased oxygen demand. Due to the excessive use of antibiotics, many bacteria causing HABP and VABP have developed resistance to existing antibiotics. Therefore, patients require new antibiotics to control bacterial infections.

Recarbrio is a fixed-dose combination of imipenem, cilastatin, and relebactam. Relebactam is a diazabicyclooctane β-lactamase inhibitor with broad-spectrum activity against β-lactamases. Although β-lactamase inhibitors lack intrinsic antibiotic activity, they enhance the efficacy of β-lactam antibiotics. Recarbrio has been granted Qualified Infectious Disease Product (QIDP) designation, Fast Track designation, and Priority Review by the U.S. Food and Drug Administration (FDA).

The safety and efficacy of Recarbrio in the treatment of HABP/VABP were evaluated in a randomized controlled clinical trial involving 535 hospitalized adult patients with HABP/VABP caused by Gram-negative bacterial infections. In this trial, 266 patients received Recarbrio, and 269 patients received piperacillin + tazobactam. Within 28 days of treatment initiation, the mortality rate was 16% among patients treated with Recarbrio and 21% among those treated with piperacillin + tazobactam.

“As a public health agency, the FDA addresses the threat of antibiotic-resistant infections by promoting the development of safe and effective new treatments,” said Dr. Sumathi Nambiar, Director of the Division of Antimicrobials in the Office of Infectious Diseases at the FDA’s Center for Drug Evaluation and Research. “These efforts provide more options for combating serious bacterial infections and ensure that patients gain access to safe and effective new therapies as soon as possible.”

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