The FDA has approved Recarbrio, a three-drug combination antibiotic, to treat adults with complicated urinary tract and intra-abdominal infections.
The federal agency's OK came with a warning about limiting the drug's use as antibiotic drug resistance grows around the globe.
Revarbio contains two previously approved antibiotics, imipenem and cilastatin, as well as relebactam, a new beta-lactamase inhibitor. It is an injection.
While the FDA approval comes as a win for antibiotic drug development, the FDA warned that to maintain the efficacy of the therapy, the drug must only be used to treat infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria.
"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, director of the Office of Antimicrobial Products at the FDA. "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."
Read the news release here.