The Food and Drug Administration (FDA) this week announced the approval of the first fecal microbiota that can be taken orally for the prevention of recurrent Clostridioides difficile infection (CDI) in people ages 18 and older following antibacterial treatment for the condition.
The product, called Vowst and made by Massachusetts-based Seres Therapeutics, contains live bacteria from human fecal matter donated by qualified people. Patients take four capsules once a day for 3 consecutive days.
In an April 26 statement, Peter Marks, MD, PhD, who directs the FDA's Center for Biologics Evaluation and Research, said, "The availability of a fecal 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."
C diff is one of the nation's most common healthcare-associated infections and is linked to 15,000 to 30,000 deaths each year. Antibiotic treatment can change the microorganisms in the gut, and other factors such as increased age and living in a nursing home can increase the risk of CDI. Treatment options are limited, but administering fecal microbiota is thought to restore gut flora to prevent more CDI episodes.
The approval follows the February publication of results from an arm of a phase 3 clinical trial, which found that the microbiome therapy, formerly called SER-109, was well tolerated and showed clinical benefit. The investigators concluded that data supports an important role for the drug as part of a paradigm shift in treating recurrent CDI.
The FDA noted that the most common side effects were abdominal bloating, fatigue, constipation, chills, and diarrhea. When the company applied for licensing, the FDA granted it priority review, breakthrough therapy, and orphan drug designations. In 2021, Seres and Nestle Health Science signed an agreement to jointly market the therapy in the United States and Canada. In December 2022, the FDA approved the first fecal microbiota preventive for CDI, Rebyota, which is given by enema.