First faecal microbiota product approved for C. diff

Rebyota, the first faecal microbiota product to prevent recurrence of Clostridioides difficile infection (CDI) in people 18 years and older after being given antibiotics for recurrent CDI, has been approved by the US Food and Drug Administration (FDA).

The approval, granted to Ferring Pharmaceuticals Inc, was given based on safety data from two randomised, double-blind, placebo-controlled studies and open-label clinical studies in the US and Canada in participants with a history of one or more CDI recurrences. Volunteers had their infection under control at the time of the study and received one or more doses of Rebyota or placebo 24 to 72 hours after completing a course of antibiotics for their CDI.

Certain factors, including taking antibiotics to treat an infection, can alter the balance of microorganisms in the gut, allowing C. diff to multiply and release toxins, which cause diarrhoea, abdominal pain and fever, and in some cases, organ failure and death. Faecal microbiota products are understood to help restore gut microbiome to prevent recurrence of CDI.

Further clinical study data for Rebyota

Across the studies, 978 individuals received at least one dose of Rebyota. The most common side effects experienced by 180 Rebyota recipients in one study, compared to 87 placebo participants, after receiving one dose of Rebyota, were abdominal pain, diarrhoea, abdominal bloating, gas and nausea.

The effectiveness of Rebyota for C. diff was evaluated in a data analysis from a randomised, double-blind, placebo-controlled, multicentre study. The analysis included 177 adults given one dose of Rebyota and 85 adults given one dose of placebo. The analysis incorporated success rates from a smaller, placebo-controlled study of 39 adults given one dose of Rebyota and one placebo dose. Data from 43 adults given two placebo doses was also assessed in the analysis. Success in preventing recurrent CDI was defined as the absence of CDI diarrhoea within 8 weeks receiving Rebyota or placebo.

Statistical analysis of both studies estimated the overall success rate over 8 weeks was 70.6 percent in the Rebyota group and 57.5 percent in the placebo group.

Hope for patients with recurrent CDI

“Today’s approval of Rebyota is an advance in caring for patients who have recurrent C. diff infection,” stated Dr Peter Marks, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening.”