The U.S. health regulator on Wednesday approved Switzerland-based Ferring Pharmaceuticals’ fecal transplant-based therapy to reduce the recurrence of a bacterial infection, making it the first therapy of its kind to be cleared in the United States.
The therapy, Rebyota, targets Clostridium difficile, or C. difficile—a superbug responsible for infections that can cause serious and life-threatening diarrhea. In the United States, the infection is associated with 15,000–30,000 deaths annually.
While this is the first such therapy approved by the Food and Drug Administration (FDA) for recurrent C. difficile infections, fecal microbiota transplants—classified by the regulator as investigational—have long been the standard of care in the United States for this condition….