FDA Approves First Fecal Microbiota Product

FDA announced the approval of Ferring Pharmaceuticals’ Rebotya for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older on Nov. 30, 2022. Rebyota, administered as a single dose rectally, is the first fecal microbiota treatment to be approved by FDA.

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

According to the release, CDI is a potentially life-threatening disease resulting in diarrhea and significant inflammation of the colon; it is associated with 15,000-30,000 deaths in the United States annually. After recovering from CDI, individuals may get the infection again — this is known as recurrent CDI. The administration of fecal microbiota is thought to facilitate restoration of gut flora (also known as gut microbiome) that can prevent further episodes of CDI.

FDA based its decision on two randomized, double-blind, placebo-controlled clinical studies (as well as open-label clinical studies) conducted in the US and Canada, where participants had a history of one or more recurrences of CDI. Patients received either Rebyota or placebo 24 to 72 hours after completion of antibiotic treatment for CDI. An analysis of the results from these studies found that prevention of recurrent CDI through eight weeks was significantly higher for patients who received Rebyota (70.6%) vs. placebo (57.5%).

Source: FDA