Rebyota FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 1, 2022.
FDA Approved: Yes (First approved November 30, 2022)
Brand name: Rebyota
Generic name: fecal microbiota, live-jslm
Dosage form: Suspension for Rectal Use
Previous Name: RBX2660
Company: Ferring Pharmaceuticals Inc.
Treatment for: Prevention of Recurrent Clostridioides difficile Infection
Rebyota (fecal microbiota, live-jslm) is a microbiota-based live biotherapeutic indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.
- Clostridioides difficile infection is a potentially life-threatening bacterial infection resulting in diarrhea and significant inflammation of the colon. It is caused by a change to the balance of microorganisms in the gut (such as after taking antibiotics to treat an infection) that allows C. difficile to multiply and release harmful toxins. After recovery from CDI, individuals may get the infection again multiple times, a condition known as recurrent CDI.
- Rebyota is a microbiota-based live biotherapeutic that works to facilitate restoration of the gut flora to prevent further episodes of CDI. It is a fecal transplant product manufactured from human fecal matter donated by screened individuals.
- Rebyota is administered rectally as a single dose 24 to 72 hours after the last dose of antibiotics for the treatment of recurrent CDI.
- The safety and efficacy of Rebyota was studied in five clinical trials with more than 1,000 participants.
- Common adverse reactions occurring in adults following a single dose of Rebyota include abdominal pain, diarrhea, abdominal distention, flatulence, and nausea.
Development timeline for Rebyota
Further information
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