www.fdanews.com/articles/211839-fda-approves-first-oral-fecal-microbiota-drug-for-c-difficile-recurrence

FDA Approves First Oral Fecal Microbiota Drug for C. Difficile Recurrence

April 28, 2023

The FDA has approved Seres Therapeutics and Nestlé Health Science’s Vowst (fecal microbiota spores, live-brpk), an oral drug, to prevent recurrence of Clostridioides difficile (C. difficile) infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI.

The agency approval makes Vowst the first orally administered microbiota-based therapeutic to treat CDI, a gastrointestinal infection that can cause diarrhea, abdominal pain and fever, and in some cases, organ failure and death. Vowst contains live bacteria and is made from donated human fecal matter.

The FDA decision was supported by phase 3 data, which showed that 88 percent of patients were recurrence-free at eight weeks post treatment and 79 percent recurrence-free at six months.