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


Seres Therapeutics and Nestlé Health Science celebrate the FDA's approval of Vowst, a first-of-its-kind orally administered microbiota-based therapeutic set to transform the lives of patients with recurrent C. difficile infections.

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.

Gut bacteria , gut flora, microbiome. Bacteria inside the small intestine, concept, representation. 3D illustration | ©Anatomy Insider | Adobe Stock

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

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