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Fecal Microbiota Product Rebyota Receives FDA Approval

The treatment is approved for preventing recurrent Clostridioides difficile infections.

The FDA has approved the first-ever fecal microbiota product. Produced by Ferring Pharmaceutical, Inc., Rebyota is approved for preventing a recurrence of Clostridioides difficile infection and should be used after a patient has completed antibiotic treatment for recurrent C difficile.1 The treatments application had Fast Track, Breakthrough Therapy, and Orphan Drug designations.

Rebyota is a single-dose treatment that is administered rectally. The product is prepared from stool donated by qualified individuals, who are test for transmissible diseases. It may contain food allergens and the potential to cause a severe reaction to food allergens is unknown at this time.

The approval is a result of 3 studies: 2 for safety and 1 for efficacy. The safety studies were conducted in the United States and Canada. All participants had a history of at least 1 recurrence of C difficile and received either 1 or more doses of Rebyota or a placebo in the 24 to 72 hours following completion of antibiotic treatment, with 978 receiving Rebyota. The most common adverse effects were gas, nausea, diarrhea, and abdominal bloating.

Efficacy was determined with a randomized, double-blind, placebo-controlled, multicenter study, with 177 adults receiving Rebyota and 85 receiving a placebo. Successful treatment was defined as lack of C difficile in the 8 weeks following administration of either Rebyota or the placebo. The investigators found that the overall estimated rate of success in preventing recurrent C difficile was 70.6% in the Rebyota group versus 57.5% in the placebo group.

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In the press release announcing the approval, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, highlighted the importance of the approval, saying, “Recurrent C difficile infection 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 C difficile infection.”

Reference

1. FDA approves first fecal microbiota product. News Release. FDA. November 30, 2022. Accessed December 1, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-first-fecal-microbiota-product


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