First fecal transplant treatment approved for use in the United States
A fecal transplant therapy called Rebyota has been approved by the United States Food and Drug Administration. A single dose can prevent a type of recurring infection in the gut
December 1, 2022
A drug called Rebyota became the first fecal transplant product approved for use by the United States Food and Drug Administration (FDA). Developed by Swiss company Ferring Pharmaceuticals, the treatment uses donated human stool to prevent recurrences Clostridioides difficile (ICD) in adults.
Between 15,000 and 30,000 people in the United States die each year from CDI, which occurs when the gut microbiota is disrupted, often by antibiotics, allowing a toxin-producing bacteria known as It’s hard multiply. Symptoms include diarrhea, abdominal pain, fever, and even organ failure. Until 25 percent of people suffer from recurrent infections after a first It’s hard infection and treatment options are limited.
Rebyota is a single dose treatment administered rectally. It uses donated human stool to restore the balance of bacteria in the gut of people who have already completed antibiotic treatment for CDI.
In an eight-week trial of 262 adults with recurrent CDI, Rebyota prevented future infections in nearly 71% of cases, compared with less than 58% of those who received a placebo.
While donors and their stools are screened for pathogens, there is still a risk of Rebyota infection, according to an FDA statement. It may also contain food allergens, although it’s unclear based on current evidence whether this could trigger an allergic reaction, the FDA said.
“As the first faecal microbiota product approved by the FDA, today’s action represents an important milestone,” said Stone Marksthe director of the Center for Biologics Evaluation and Research of the FDA, in a Press release from November 30.
While doctors can perform fecal transplants to treat recurrent CDI and other conditions, the FDA considers the procedure experimental and rarely regulates the procedure as long as the donors and the stool they use are screened for infectious diseases.
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