FDA approves product to prevent recurrence of C. difficile infection

Dec. 1, 2022

The U.S. Food and Drug Administration has approved Rebyota, the first fecal microbiota product approved by the agency. 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.

“The approval of Rebyota is an advance in caring for patients who have recurrent C. difficile infection,” said Peter Marks, M.D., Ph.D., 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, this 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 resulting in diarrhea and significant inflammation of the colon. In the United States, CDI is associated with 15,000-30,000 deaths annually. 

The intestinal tract contains millions of microorganisms, often referred to as the “gut flora," or "gut microbiome." Certain situations, such as taking antibiotics to treat an infection, may change the balance of microorganisms in the gut, allowing C. difficile to multiply and release toxins causing diarrhea, abdominal pain and fever, and in some cases, organ failure and death. 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. After recovering from CDI, individuals may get the infection again—often multiple times—a condition known as recurrent CDI. The risk of additional recurrences increases with each infection and treatment options for recurrent CDI are limited. The administration of fecal microbiota is thought to facilitate restoration of the gut flora to prevent further episodes of CDI.

FDA release

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