FDA Approves First Fecal Transplant Therapy

The FDA has approved Ferring Pharmaceuticals’ fecal transplant therapy Rebyota for the prevention of recurrence of C. difficile infection (CDI) in individuals that have completed antibiotic treatment for recurrent CDI.

As the first FDA-approved fecal microbiota product the action “represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Administered rectally as a single dose, Rebyota is prepared from stool donated by qualified individuals. The donors and the donated stool are tested for a panel of transmissible pathogens, because Rebyota may carry a risk of transmitting infectious agents, the FDA said.

The Ferring application was granted Fast Track, Breakthrough Therapy and Orphan designations.