Ferring Launches First Microbiome Therapy to Prevent C. Diff Infection

Ferring Pharmaceuticals has introduced Rebyota (fecal microbiota, live – jslm), the first microbiota product to prevent the recurrence of Clostridioides difficile (C. diff) infection (CDI). It is indicated for use in people 18 years of age and older. Rebyota is provided in a pre-packaged, single-dose 150 mL microbiota suspension for rectal administration consisting of a liquid mix of up to trillions of live microbes.

Ferring officials would not provide a list price for Rebyota, but a spokesperson said the company is committed to making the therapy accessible to patients. The company offers a copay program for insured patients, who may pay $100 for each Rebyota prescription, and a patient assistance program for those who are uninsured or underinsured.

The human microbiome is a complex community of microorganisms in and on the body. In the gut, if a microbial imbalance occurs, this can lead to C. diff, irritable bowel syndrome or even diabetes. C. diff is a serious disease that causes severe diarrhea, fever, stomach tenderness or pain, loss of appetite, nausea, and colitis. It has been estimated that up to 35% of cases recur after initial diagnosis.

Related: FDA Advisory Committee Gives Positive Vote for Microbiota-based C. Diff Therapy

The FDA approved Rebyota in November 2022, after a positive vote from an FDA advisory committee. The approval is based on the results from the clinical program including the phase 3 PUNCH CD3 trial in which a single dose of Rebyota demonstrated superiority to placebo to reduce recurrence of C. diff infection after standard-of-care antibiotic treatment. The success rate at eight weeks for Rebyota was 70.6% versus 57.5% for placebo. More than 90% of study participants who achieved treatment success remained free of C. diffinfection recurrence through six months.

Adverse events were primarily mild-to-moderate, and there were no treatment-related serious adverse events. Incidence of treatment-emergent adverse events was higher in Rebyota recipients compared with placebo, mostly driven by a higher incidence of mild gastrointestinal events.