FDA-Approved Oral Fecal Microbiota Therapy for Prevention of Recurrent C. difficile Infection

Standard treatments for Clostridioides difficile infection (CDI), while highly effective for resolving the initial episode, are limited by frequent recurrence (probably due to persistent disruption of the intestinal microbiome). Fecal microbiota therapy (FMT) after CDI treatment is recommended for patients with multiple episodes. FMT may be difficult to access when stool banks or directed donors supply the fecal material. These processes occur in a confusing regulatory environment with little standardization and often at significant expense to the patient as payors generally do not cover the cost of product obtained from stool banks.

Authorized Population

VOWST is indicated for the prevention of subsequent episodes of CDI in those 18 years of…