First faecal transplant treatment approved for use in the US

A drug called Rebyota has become the first faecal transplant product approved for use by the US Food and Drug Administration (FDA). Developed by Swiss company Ferring Pharmaceuticals, the treatment uses donated human stool to prevent recurrent Clostridioides difficile infections (CDI) in adults.

Between 15,000 and 30,000 people in the US die each year due to CDI, which occurs when the gut microbiome is disrupted, often by antibiotics, allowing a toxin-producing bacterium known as C. difficile to multiply. Symptoms include diarrhoea, abdominal pain, fever and even organ failure. Up to 25 per cent of people experience recurrent infections after a first C. difficile infection, and treatment options are limited.

Rebyota is a single-dose treatment administered through the rectum. It uses donated human stool to restore the balance of bacteria in the gut of individuals who have already completed antibiotic treatment for CDI.

In an eight-week trial of 262 adults with recurrent CDI, Rebyota prevented future infections in nearly 71 per cent of cases, whereas the same was true for less than 58 per cent of those given a placebo.

While donors and their stool are screened for pathogens, there is still a risk of infection with Rebyota, according to a statement from the FDA. It may also contain food allergens, although it is unclear based on current evidence if this could trigger an allergic reaction, the FDA said.

“As the first FDA-approved fecal microbiota product, today’s action represents an important milestone,” said Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, in a news release from 30 November.

While doctors can perform faecal transplants to treat recurrent CDI and other conditions, the FDA considers the procedure experimental, and it rarely regulates the procedure so long as donors and the stool they use are screened for infectious diseases.

“This is a new frontier in medicine. We are just at the beginning of learning how microbes affect health and disease, and the approval of this therapy will help us study microbiome-based therapies in diseases beyond C. difficile,” says Sahil Khanna at the Mayo Clinic in Minnesota.

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