The product, Vowst, is approved for the prevention of recurrence of Clostridioides difficile infection (CDI) in adults, following antibacterial treatment for recurrent CDI.
The pill contains healthy bacteria found in human waste to fight gut infections, providing an easier way of performing so-called faecal transplants.
“Today’s approval provides patients and healthcare providers a new way to help prevent recurrent C. difficile infection,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
“The availability of a faecal microbiota product that can be taken orally is a significant step forward in advancing patient care and accessibility for individuals who have experienced this disease that can be potentially life-threatening.”
The product, created by Seres Therapeutics in partnership with Nestlé Health Sciences, provides a simpler version of stool-based procedures that have been used for more than a decade. It comes as a regimen of four daily capsules taken for three consecutive days.
The administration of faecal microbiota is thought to facilitate restoration of the gut flora, preventing further episodes of CDI.
CDI: A common healthcare-associated infection
CDI, caused by the bacterium C. difficile, is one of the most common healthcare-associated infections, accounting for almost half of all gastrointestinal infections in hospitals in Europe. Often caused by antibiotic treatment, which can change the balance of microorganisms in the gut, CDI causes diarrhoea, abdominal pain, fever, and – in some cases – organ failure and death.
Other risk factors that contribute to increased risk of CDI include being over 65 years of age, being hospitalised or resident in a nursing home, and having a weakened immune system and/or a history of CDI.
Many individuals go on to develop the infection again, a condition known as recurrent CDI. The risk of additional recurrences increases with each infection and treatment options for recurrent CDI are limited.
“Recurrent C. difficile infection significantly impacts patients’ quality of life, both physically and emotionally, leaving many living in tremendous fear of future recurrences,” said Christian John Lillis, executive director at the Peggy Lillis Foundation for C. Diff Education and Advocacy. “Patients have been waiting for new treatment options that address a key concern: prevention of an additional CDI recurrence.”
Faecal transplant product reduces CDI recurrence to 12.4%
The product’s efficacy was evaluated in a randomised, placebo-controlled clinical study in which 89 participants received Vowst and 93 participants received a placebo. Eight weeks after treatment, CDI recurrence in Vowst-treated participants was lower compared with placebo-treated participants (12.4% versus 39.8%). The results were reported in Jama Network Open.
“Recurrent C. difficile infection is a highly debilitating and life-threatening disease, and antibiotics alone do not address the underlying cause of recurrent CDI – dysbiosis of the gut microbiome,” said Carl Crawford, assistant professor of clinical medicine at Weill Cornell Medical College.
“The approval of Vowst provides an important new oral treatment option for this disease, and I am pleased to now be able to offer this medicine to recurrent CDI patients.”
The product contains live bacteria and is manufactured from human faecal matter that has been donated by qualified individuals. Donors and donated stool are tested for transmissible pathogens, but a potential risk of transmitting infectious agents remains, while the potential of Vowst to cause adverse reactions due to food allergens is unknown.