The U.S. Food and Drug Administration (FDA) has approved Swiss pharmaceutical company Ferring’s bacterial transplant to reduce reinfection. This is the first drug to be licensed using this approach.
Rebyota attacks Clostridium difficile, or C. difficile for short, the virus that causes infections that can lead to acute, life-threatening diarrhea. The virus kills 15,000 to 30,000 people a year in the United States.
Although this is the first FDA-approved drug to treat an infection caused by C. difficile using this approach, fecal microbiota therapy has long been considered a scientific treatment.
“The first FDA-approved fecal microbiome product is an important milestone as an alternative option for the prevention of recurrent infections,” said Peter Marks, director of the Center for Research and Development, according to the FDA’s Biological Review.
Rebyota is inserted into an enema to replenish beneficial gut bacteria with bacteria extracted from the stool of a healthy donor.
In addition to Ferring, several pharmaceutical companies, including Seres Therapeutics, are also developing oral drugs based on fecal microbiome cultures.