The product called Rebyota is manufactured from human feces.
is a bacterium that causes potentially life-threatening diarrhea and inflammation of the colon. It is usually a side effect of taking antibiotics long-term, which changes the balance of microorganisms in the gut. This allows the bacteria to grow and release toxins causing diarrhea, abdominal pain, fever, and in some cases, organ failure and death.
“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening. As the first FDA-approved fecal microbiota product, today’s action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.The newly approved therapy uses samples of microbes obtained from the.
Over 90% of subjects in the Rebyota group, who had treatment success, were found to be CDI recurrence-free for six months.Safety was assessed in 2 randomized, double-blind, placebo-controlled clinical studies and three open-label clinical studies. A total of 978 adults received at least one dose of Rebyota. The most common adverse reactions reported with treatment included abdominal pain/distention, diarrhea, flatulence, and nausea.
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