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.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a Swiss multinational biopharmaceutical company specialising in areas such as reproductive health, maternal health, gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years. Headquartered in Saint-Prex, Switzerland, Ferring has its own manufacturing facilities in several European countries, in South America, China, India, and the United States. Founded in 1950, privately-owned Ferring employs more than 5,400 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.
December 2, 2022