FDA approved

FDA Approves Rebyota: The First Fecal Transplant Therapy

  • December 7, 2022
  • 2 mins read

On November 30, 2022, Rebyota, the FDA approved first fecal transplant therapy for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals aged 18 years and older. This fecal transplant therapy is for use after an individual has completed antibiotic treatment for recurrent Clostridioides Difficile Infection.

Clostridioides difficile (C. difficile) is a bacterium that can cause CDI, a potentially hazardous and life-threatening disease resulting in diarrhea and significant inflammation of the colon. Clostridioides difficile infection is associated with up to 30,000 deaths each year.

This fecal transplant therapy fights Clostridium difficile, or C. difficile, which typically leads to infections that can be responsible for causing life-threatening diarrhea and inflammation of the colon.

According to the FDA, Rebyota is the “First Fecal Microbiota product” approved by the agency.

Rebyota therapy uses samples of microbes obtained from the donor poop. It is administered rectally as a single dose and adds good gut bacteria, which is absolutely crucial to healthy digestion.

Rebyota is formulated from the stool donated by qualified individuals. Donors and the donated stool are examined for a panel of transmissible pathogens, although therapy Rebyota is manufactured from human fecal matter, it may be responsible for carrying a probability of transmitting infectious agents.

In addition, this fecal transplant therapy may contain food allergens; the risk for the product to cause side effects because food allergens is not known.

“Approval of Rebyota is an advance in caring for all those who have recurrent C. difficile infection (CDI),” said Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “Recurrent Clostridioides difficile infection impacts an individual’s QoL and can also potentially be hazardous. As the first FDA-approved fecal transplant therapy, this action represents a promising milestone, as it provides an additional approved treatment option in order to prevent recurrent Clostridioides difficile infection.”

The Food and Drug Administration granted approval of Rebyota: fecal transplant therapy to Ferring Pharmaceuticals Inc.

Reference: https://www.fda.gov/news-events/press-announcements/fda-approves-first-fecal-microbiota-product