Positive CHMP opinion for Recarbrio for the treatment of infections due to aerobic gram-negative organisms in adults with limited treatment options.- Merck Inc.

Merck Inc., announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Recarbrio (imipenem, cilastatin, and relebactam), a new combination antibacterial agent, for approval. If approved by the European Commission, Recarbrio would be indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Recarbrio was approved by the FDA in July 2019 for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and complicated intra-abdominal infections (cIAI) caused by susceptible Gram-negative bacteria, in adults who have limited or no alternative treatment options.