FDA Approves First Fecal Transplant Therapy

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Dec. 1, 2022 -- For the first time, the FDA has given approval for a fecal transplant therapy that can treat a bacterial infection associated with up to 30,000 deaths each year.

The treatment fights Clostridium difficile, or C.difficile, which leads to infections that can cause life-threatening diarrhea and inflammation of the colon.

The FDA said it is the “first fecal microbiota product” approved by the agency.

Called Rebyota, the therapy uses samples of microbes obtained from donor poop. It is administered through the rectum and adds good gut bacteria, which is important to healthy digestion.

“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.”

The FDA says certain situations, such as using antibiotics, can change the balance of microorganisms in the gut, allowing C. difficile to grow and release poisons. This can lead to diarrhea, abdominal pain, fever, organ failure, and death.

The risks for getting CDI include being over age 65 and having a weakened immune system. Patients can get it again even after it’s been successfully treated. 

“The risk of additional recurrences increases with each infection and treatment options for recurrent CDI are limited,” the FDA said. “The administration of fecal microbiota is thought to facilitate restoration of the gut flora to prevent further episodes of CDI.”

Swiss Ferring Pharmaceuticals became the owner of this therapy through its 2018 purchase of U.S.-based Rebiotix, Reuters reported.