FDA Approves Microbiome Therapeutic Vowst to Prevent Recurrence of C. difficile Infections in Adults

Seres Therapeutics, Inc. and Nestlé Health Science announce a significant milestone in microbiome therapeutics as FDA grants approval for Vowst, an orally administered microbiota-based therapeutic designed to prevent the recurrence of C. difficile infections (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI). Previously known as SER-109, Vowst has the potential to improve the quality of life for patients with rCDI, including those who have experienced their first recurrence.

The approval comes on the heels of the successful Phase 3 study, which showed 88% of treated individuals were recurrence-free at 8 weeks. Set to be available in June, Vowst addresses a significant unmet need as recurrent CDI is a leading cause of hospital-acquired infection that can lead to severe illness and even death. With an estimated 156,000 episodes projected in the U.S. in 2023, the FDA's approval of VOWST™ marks a transformative moment for patients, caregivers, and healthcare professionals alike.

Reference: Seres Therapeutics and Nestlé Health Science Announce FDA Approval of VOWSTTM (fecal microbiota spores, live-brpk) for Prevention of Recurrence of C. difficile Infection in Adults Following Antibacterial Treatment for Recurrent CDI. Cambridge, MA and Hoboken, NJ | April 26, 2023 / Business Wire