FDA Gives First-Ever Approval to Fecal Transplant Therapy

The Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. Andrew Kelly/Reuters

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.