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Seres Therapeutics and Nestlé Health Science Receive the US FDA’s Approval of VOWST for the Prevention of Recurrence of C. Difficile Infection

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Seres Therapeutics

Seres Therapeutics and Nestlé Health Science Receive the US FDA’s Approval of VOWST for the Prevention of Recurrence of C. Difficile Infection

Shots:

  • The US FDA has approved VOWST (formerly called SER-109), an orally administered microbiota-based therapeutic which is expected to be available in June
  • The approval was based on the results from the P-III (ECOSPOR III & IV) published in the NEJM & the JAMA Network Open evaluating VOWST vs PBO in 182 & 263 adult patients. The (ECOSPOR III) trial showed a reduction in CDI recurrence @8wks., (~88% vs 60%) were recurrence-free @8wks.; 79% vs 53% at 6mos. post-treatment, no treatment-related SAEs were seen & the frequency of TRAEs was similar b/w treatment arms
  • The (ECOSPOR IV) study results contributed to the VOWST safety database & supported product approval. Seres & Nestlé Health Science collaborated in July 2021 to jointly commercialize VOWST in the US & Canada

Ref: Seres Therapeutics  | Image: Seres Therapeutics 

Related News:- Seres Therapeutics Reports P-III Trial (ECOSPOR IV) Results of SER-109 for the Prevention of Recurrent C. Difficile Infection

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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