Approved: First Fecal Microbiota Product

FDA approves Rebyota to prevent recurring Clostridioides difficile infection

(RxWiki News) The US Food and Drug Administration (FDA) recently approved a type of product they've never approved before.

And it prevents the recurrence of Clostridioides difficile infection, a potentially serious health problem.

It's called Rebyota. And it's the first fecal microbiota product the FDA has ever approved.

What does that mean, exactly? It's a treatment made from donated stool.

The idea is that antibiotics used to treat Clostridioides difficile infection can change the balance of bacteria in the gut in a way that allows the infection to recur. In certain individuals, the illness resulting from this infection can be serious — even potentially deadly.

Rebyota is meant to speed up the reintroduction of beneficial bacteria in the gut. That, according to the FDA, can help the body fight off a recurring Clostridioides difficile infection.

Administered as a single rectal dose after a course of antibiotics, Rebyota is made from donated fecal matter. Donors are screened for pathogens that could be transmitted via fecal matter. The FDA noted that this drug could contain food allergens, but it wasn't clear whether it could cause allergic reactions as a result.

In a study of the effectiveness of Rebyota, 70.6 percent of those who received the treatment avoided Clostridioides difficile reinfection. In the group who received a placebo treatment, only 57.5 percent avoided reinfection.

Side effects of Rebyota included nausea, gas, bloating, diarrhea and stomach pain, according to the FDA.

The FDA granted approval of Rebyota to Ferring Pharmaceuticals Inc.

Review Date: 
December 8, 2022