FDA Approves Pharmaceutical Fecal Transplant Product

FDA News Release (11/30/22): FDA Approves First Fecal Microbiota Product

“Rebyota is approved for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older. It is for use after an individual has completed antibiotic treatment for recurrent CDI.”

“Rebyota is administered rectally as a single dose [150 mL]. Rebyota is prepared from stool donated by qualified individuals….The effectiveness of Rebyota was evaluated in an analysis of data from a randomized, double-blind, placebo-controlled, multicenter study….the overall estimated rate of success in preventing recurrent CDI through 8 weeks was significantly higher in the Rebyota group (70.6%) than in the placebo group (57.5%).”

My take: As pharmaceutical companies gain approval for fecal transplant products, I would anticipate a significant increase in costs. This product seemed to have a fairly low success rate compared to placebo.

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White Sands National Park. New Mexico.