FDA approves first fecal microbiota treatment

Dec. 7, 2022

Last week, the U.S. FDA approved the first fecal microbiota therapy Rebyota, for the prevention of the recurrence of Clostridioides difficile infection (CDI) in adults.

The landmark approval doesn’t come as a surprise, as a few months ago during the Vaccines and Related Biological Products Advisory Committee meeting, members backed Ferring Therapeutics’ microbiota biotherapeutic, voting to recommend it for approval. 

Patients with CDI usually face a high mortality rate due to the bacteria's antibiotic-resistant nature, and according to Ferring, Rebyota yields its therapeutic effect by replenishing or replacing disrupted microbial communities. 

The drug is prepared from stool donated by qualified individuals and administered rectally as a single dose. Its approval hinged on several randomized double-blind, placebo-controlled clinical studies and from open-label clinical studies conducted in the United States and in Canada, as well as a randomized, double-blind, placebo-controlled, multicenter study to asses effectiveness. 

In a statistical analysis that took into account both studies, Rebyota’s overall estimated rate of success in preventing recurrent CDI through 8 weeks was 70.6% in the Rebyota group, which was significantly higher than 57.5% reported in the placebo group. 

Rebyota had been granted Fast Track, Breakthrough Therapy as well as Orphan designation.