US Food and Drug Administration approves Recarbrio

Recarbrio (imipenem, cilastatin and relebactam), an antibacterial drug product to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI), has been approved by the US Food and Drug Administration (FDA).

Recarbrio is a three-drug combination injection containing imipenem-cilastatin, a previously FDA-approved antibiotic and relebactam, a new beta-lactamase inhibitor.

The safety of Recarbrio, administered via injection, was studied in two trials, one each for cUTI and cIAI. The cUTI trial included 298 adult patients with 99 treated with the proposed dose of Recarbrio. The cIAI trial included 347 patients with 117 treated with the proposed dose of Recarbrio. The most common adverse reactions observed in patients included nausea, diarrhea, headache, fever and increased liver enzymes.

“The FDA remains focused on facilitating the development of safe and effective new antibacterial drugs to give patients more options to fight serious infections,” said Ed Cox, MD, MPH, Director for the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “It is important that the use of Recarbrio be reserved for situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection.” 

Recarbrio received FDA’s Qualified Infectious Disease Product (QIDP) designation, which is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. As part of QIDP designation, Recarbrio was granted Priority Review under which the FDA’s goal is to take action on an application within an expedited time frame.