First fecal microbiome-restoration therapy approved by Health Canada

Clostridioides difficile infection (CDI) is the most common cause of infectious diarrhea in hospitalized patients in Canada.1 It is associated with significant clinical and socioeconomic burdens.2 Risk factors for recurrent CDI include antibiotic use, age ≥ 65 years, hospital admission, comorbid conditions (e.g., chronic kidney disease, inflammatory bowel disease), immunosuppression and a history of CDI.2The recurrence rate after antibiotic treatment for an initial episode of CDI is typically 20%–25%. Patients who have one recurrent episode have up to a 35% chance of having another, and those with three or more CDI episodes have up to a 65% chance of additional recurrences. Most CDI recurrences develop within 60 days after stopping antibiotic treatment; the risk is greatest in the first two weeks.3Health Canada has now approved Ferring’s Rebyota (fecal microbiota, live, rectal suspension) for C. difficile prevention. It is indicated for the prevention of recurrence of CDI in adults following antibiotic treatment for recurrent CDI. It is not indicated for the treatment of CDI.1,4Rebyota is classified as a microbiome restoration therapy. Its exact mechanism of action has not been established.4A single 150 mL dose of microbiota suspension administered rectally is recommended, given 24–72 hours after the last dose of antibiotics for CDI. It should not be administered during antibiotic treatment for CDI, and no oral antibiotic therapy should be given for up to eight weeks after administration of the microbiota suspension unless directed by a physician. Additional treatment with Rebyota may be administered in the event of CDI recurrence.4 Prior to use, the frozen microbiota suspension should be thawed completely, then administered rectally by gravity flow using the supplied administration set.4Medical Letter consultants report that in a key clinical trial, the estimated rate of treatment success (absence of CDI diarrhea for 8 weeks after treatment) was 70.6% with a single dose of Rebyota and 57.5% with placebo.3 The manufacturer also recently reported results from the Canadian cohort (n=117) of an open label study. Treatment success was achieved by 75.2% (88/117) of patients who received Rebyota after standard-of-care antibiotics. Sustained clinical response at six months was attained by 90.9% (80/88) of participants who had achieved treatment success at eight weeks.1Rebyota is generally well tolerated. The most common adverse effects are abdominal pain, diarrhea, abdominal distension, flatulence and nausea. Most of these adverse effects are mild to moderate in severity and occur within the first two weeks following treatment. No serious adverse effects have specifically been attributed to the microbiota suspension. However, the product is manufactured from human fecal matter and, therefore, may contain food allergens and carry a risk of transmitting infectious agents.4 The microbiota suspension is not absorbed into the body. As a result, no metabolic drug–drug interactions are expected.4Rebyota contains live microorganisms; therefore, it is important to follow the recommended storage requirements. The product should be stored in an ultracold freezer at -60° to -90°C until the product expiration date. Alternatively, it can be stored in the refrigerator (2°C–8°C) for up to five days (including the 24-hour thawing period). Before use, the suspension should be thawed completely by placing the carton in a refrigerator for about 24 hours. The suspension must not be thawed at room temperature or by using a heat source (e.g., microwave, hot water), and must not be refrozen once thawed. The shelf-life is 36 months from date of manufacture if stored in an ultracold freezer.4Rebyota will be supplied in cartons containing one prepackaged single-dose microbiota suspension (150 mL). An administration set to facilitate rectal administration will be packaged separately.4 Ferring has not yet announced a specific launch date for Rebyota in Canada, but the company is working to make the product available as soon as possible. ReferencesFerring Pharmaceuticals. Ferring Inc. receives Health Canada approval for Rebyota (fecal microbiota, live). March 6, 2025. (accessed March 13, 2025).Feuerstadt P, Chopra T, Knapple W, et al. PUNCH CD3-OLS: a phase 3 prospective observational cohort study to evaluate the safety and efficacy of fecal microbiota, live-jslm (Rebyota) in adults with recurrent Clostridioides difficile infection. Clin Infect Dis 2025;80(1):43-51. (accessed March 13, 2025).Anon. Live fecal microbiota (Rebyota) for prevention of CDI recurrence. Med Lett Drugs Ther 2023;65:35-6.Ferring Inc. Rebyota (fecal microbiota, live) product monograph. (accessed March 13, 2025).

First fecal microbiome-restoration therapy approved by Health Canada

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