FDA Approves Preventative Medication for Recurrent C. difficile Infection

May 3, 2023

On April 26, 2023, The US FDA announced approval of VOWST, formerly known as SER-109, for preventing recurrence of C. difficile. C. difficile is a major health threat, with 200,000 cases in American hospitals and over 12,000 deaths per year. VOWST is an orally administered microbiota-based medication and is the first of its kind to be approved. Clinical trials found that VOWST reduced the recurrence of C. difficile at rates nearly 50% higher than placebo controls. Studies found this at both 8 weeks and 6 months after intervention. ENCORE Borland Groover Clinical Research participated in the clinical trials ECOSPOR III and ECOSPOR IV and helped pave the way for this exciting, safe, and effective new medication. Nestlé Health Science and Seres Therapeutics expect VOWST to be available by June of 2023.



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