The therapy, Rebyota, targets Clostridium difficile, or C. difficile – a superbug responsible for infections that can cause serious and life-threatening diarrhea.
-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.
While this is the first such therapy approved by the Food and Drug Administration for recurrent C. difficile infections, fecal microbiota transplants – classified by the regulator as investigational – have long been the standard of care in the U.S. for this condition. Rebyota is delivered through an enema and works by replenishing good gut bacteria through samples of microbes distilled from faeces of healthy donors.
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U.S. FDA gives first-ever approval to fecal transplant therapyThe 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.
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FDA OKs First Fecal Transplant Therapy for Recurrent C difficileRebyota, a microbiota-based live biotherapeutic prepared from human stool, is intended for use after an individual has completed antibiotic treatment for recurrent C difficile infection.
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