On November 30, 2022, Ferring Pharmaceuticals announced that its microbiome therapy REBYOTA® (RBX2660) was approved by the FDA, becoming the first approved fecal microbial therapy. It is mainly used to prevent the recurrence of Clostridium difficile infection (CDI) in people aged 18 and over after receiving antibiotic treatment.
Clostridium difficile (C. difficile) is a bacterium that causes CDI, a potentially life-threatening condition that causes diarrhea and severe colonic inflammation. In the United States, CDI is associated with 15,000–30,000 deaths per year.
Rebyota is a microbiome therapy for the prevention of Clostridium difficile infection. It does not contain any antibiotics and is designed to help patients restore the intestinal microflora and avoid reinfection of CDI. Rebyota is administered as a single rectal dose and is made from the stool of an eligible donor. Before using the donated stool, the donor and his stool will undergo a series of tests to confirm the presence of pathogenic bacteria that can cause infection. The therapy has been granted Fast Track Qualification, Orphan Drug Qualification and Breakthrough Therapy Designation (BTD) by the US FDA.
Rebyota is made from qualified donor feces and is administered rectally in a single dose. Given the risk that fecal material may contain transmissible pathogens, the donor and donor stool were tested for transmissible pathogens. In addition, Rebyota may contain food allergens, but the potential for this product to cause adverse reactions due to food allergens is unknown.
In the comprehensive analysis of two clinical trials, it was shown that Rebyota can effectively prevent the recurrence of CDI in patients. The analysis showed that 70.6% of patients in the Rebyota group successfully avoided CDI recurrence, which was significantly better than 57.5% in the placebo group. In terms of safety, a data involving 180 patients in the Rebyota group and 87 patients in the placebo group showed that the most common adverse reactions in the drug group after receiving a dose of Rebyota were abdominal pain, diarrhea, abdominal distension, flatulence, and nausea.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said: “The approval of Rebyota is a big step forward for patients with recurrent CDI. Recurrent CDI affects the quality of life of individuals and may also be life-threatening. Today’s approval is a great step forward.” Important milestone, as the first FDA-approved fecal microbial product provides a new option for the prevention of recurrent CDI.”