DECEMBER 2, 2022

FDA Approves Rebyota, the First Live Biotherapeutic Fecal Microbiota Product in the U.S.

By Landon Gray

RBX2660 (Rebyota, Ferring) is approved by the FDA for the prevention of recurrent Clostridioides difficile infection (CDI) in adults who are at least 18 years of age, and is intended for use after a patient has completed antibiotic treatment for CDI recurrence.

“Today’s approval of Rebyota is an advance in caring for patients who have recurrent C. difficile infection,” said Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and