FDA approves first fecal transplant product

The drug, Rebyota, became the first fecal transplant product approved for use by the U.S. Food and Drug Administration (FDA). The treatment, developed by the Swiss pharmaceutical company Ferring, uses faeces from healthy donors to prevent recurrent Clostridium difficile (CDI) infections in adults. In the United States, between 15,000 and 30,000 people die each year from CDI. It occurs because the gut microbiota is disrupted by antibiotics, leading to the proliferation of a toxin-producing bacterium known as CDI. Symptoms of the disease include diarrhea, abdominal pain, fever and even organ failure, and up to 25 percent of patients experience recurrent infections after their first infection. Treatment options for this disease are limited. Rebyota is a single-dose therapy administered rectally. It uses feces from healthy donors to restore the bacterial balance in the gut of patients who have completed antibiotic therapy for CDI.

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