The Food and Drug Administration (FDA) has approved Rebyota® (fecal microbiota, live-jslm) for the prevention of recurrence of Clostridioides difficile infection (CDI) in patients 18 years of age and older following antibiotic treatment for recurrent CDI.
Rebyota is a fecal microbiota suspension for rectal administration. The product is manufactured from human fecal matter sourced from qualified donors and is tested for transmissible pathogens.
The approval was based on data from the pivotal phase 3 PUNCH CD3 (ClinicalTrials.gov Identifier: NCT03244644) and phase 2 PUNCH CD2 (ClinicalTrials.gov Identifier: NCT02299570) trials, which compared the efficacy and safety of Rebyota to placebo in patients 18 years of age and older who had CDI recurrence after a primary episode of CDI.
In the phase 3 study, a total of 262 adults were randomly assigned to receive Rebyota (n=177) or placebo (n=85). The primary endpoint was treatment success defined as the absence of CDI diarrhea through 8 weeks.
Results using a Bayesian analysis of data showed that the estimated rate of treatment success at 8 weeks was significantly higher with Rebyota (70.6% [95% CI, 64.1-76.8]) compared with placebo (57.5% [95% CI, 48.1-67.1]) (treatment difference, 13%; 95% CI, 2.3-24). Rebyota demonstrated a 99.1% posterior probability of superiority to placebo.
“As the first FDA-approved fecal microbiota product, today’s action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
Safety was assessed from 2 randomized, double-blind, placebo-controlled clinical studies and 3 open-label clinical studies. A total of 978 adults received at least 1 dose of Rebyota. The most common adverse reactions reported with treatment included abdominal pain/distention, diarrhea, flatulence, and nausea. As the product is manufactured from human fecal matter, there is a risk it may carry infectious agents or food allergens.
Rebyota is supplied as a rectal suspension; a single dose is 150mL. The product is administered rectally 24 to 72 hours after the last dose of antibiotics for CDI.
- Ferring receives US FDA approval for Rebyota® (fecal microbiota, live-jslm) – a novel first-in-class microbiota-based live biotherapeutic. News release. November 30, 2022. https://ferringusa.com/?press=ferring-receives-u-s-fda-approval-for-rebyota-fecal-microbiota-live-jslm-a-novel-first-in-class-microbiota-based-live-biotherapeutic.
- FDA approves first fecal microbiota product. News release. November 30, 2022. https://www.prnewswire.com/news-releases/fda-approves-first-fecal-microbiota-product-301690762.html.
- Rebyota. Package insert. Ferring Pharmaceuticals; 2022. Accessed December 1, 2022. https://www.ferringusa.com/wp-content/uploads/sites/12/2022/11/rebyota-package-insert-pdf-11.2022.pdf.
This article originally appeared on MPR