The FDA announced on Nov. 30 that it has approved the first fecal microbiota product.
Rebyota is approved for the prevention of recurrent Clostridioides difficile infection (CDI) in adults who have already completed antibiotic treatment for a recurrence. It is prepared from donated, tested stool and administered rectally as a single dose.
The FDA based its approval on two trials in patients with previous recurrences of CDI that found a higher success rate in preventing additional recurrence through eight weeks with the drug than with placebo (70.6% vs. 57.5%). The most common side effects were abdominal pain, diarrhea, abdominal bloating, gas, and nausea. The FDA also noted that although the stool is screened, the drug may carry a risk of transmitting infectious agents or containing food allergens.