FDA Approves Merck’s Recarbrio
The FDA has approved Merck’s antibacterial drug Recarbrio for treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).
The three-drug combination injection includes imipenem-cilastatin, a previously approved antibiotic, and relebactam, a new beta-lactamase inhibitor.
The approval was supported by results from two trials. The cUTI trial included 298 adult patients with 99 treated with Recarbrio. The cIAI trial included 347 patients with 117 treated with Recarbrio.
The drug received priority review as a Qualified Infectious Disease Product, a designation for antibacterial and antifungal drug products intended to treat serious or life-threatening infections.