FDA Approves First Fecal Transplant Therapy

The US Food and Drug Administration (FDA) approved Rebyota, the first fecal transplant therapy to prevent the recurrence of potentially life-threatening Clostridioides difficile infection (CDI).

The fecal microbiota product Rebyota, administered rectally as a single dose, is approved to use in individuals 18 and older who have completed antibiotic treatment for recurrent CDI.

“Today’s approval of Rebyota is an advance in caring for patients who have recurrent C. difficile infection,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “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.”

Clostridioides difficile (C. difficile) is a bacterium that can cause CDI, a potentially life-threatening disease. CDI may result in diarrhea, abdominal pain, fever, and in some cases, organ failure and death.

In the US, CDI is associated with 15,000-30,000 deaths annually, according to the FDA.

Certain situations, such as taking antibiotics, may change the “gut flora” balance, allowing C. difficile to multiply and release toxins.

Other factors that can increase the risk for CDI include age older than 65 years, hospitalization, a weakened immune system, and a previous history of CDI.

Rebyota is prepared from stool donated by qualified individuals. Even though donors and the donated stool are tested for transmissible pathogens, Rebyota may carry a risk of transmitting infectious agents and may contain food allergens.

In a statistical analysis of two studies evaluating Rebyota’s safety and effectiveness, 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%).


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