On June 4th, 2020 the FDA approved Recarbrio (imipenem-cilastatin and relebactam) to treat HAP/VAP in patients over 18 years old. This drug includes imipenem, which binds to PBP 2 and PBP 1B on certain bacteria therefore inhibiting PBP leading to the disruption of bacterial cell wall synthesis, and cilastatin which is a renal dehydropeptidase inhibitor that limits the renal metabolism of imipenem. The third ingredient in Recarbrio is relebactam, a beta-lactamase inhibitor that protects imipenem from degradation. Recarbrio was previously indicated to treat patients with complicated urinary tract infections and complicated intra-abdominal infections as a last line treatment. Recarbrio is supplied as 1.25g vial for dilution and is given intravenously to be infused over 30 minutes.
The FDA states that one of its jobs as a public health agency is to address the threat of antimicrobial resistant infections by facilitating the development of safe and effective new treatments, which is why Recarbrio was granted the new indications. The application was given a Qualified Infectious Disease program (QIDP), fast track, and priority review designations. A QIDP is for antifungal and antibacterial drug products that are intended to treat serious or life threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act.
By: Magdaliene Vricos, PharmD Candidate 2021