FDA Approves First Oral Fecal Microbiota Product for Preventing Recurrent C. difficile Infection

The US FDA has approved Vowst, the first fecal microbiota product that can be taken orally, according to a press release from Seres Therapeutics and Nestlé Health Science.[0] Vowst is approved for preventing the recurrence of Clostridioides difficile infection (CDI) in adults who are 18 years of age and older, following antibacterial treatment for recurrent CDI.[1] In a randomized double-blind trial involving 79 participants aged 18 years and older, high-dose VE303 prevented more cases of recurrent CDI infection compared with a lower dose medication or placebo. The low recurrence rate with high-dose VE303 as well as the absolute risk reduction of 30.5% versus placebo compares favorably to other microbiota products tested in trials, including the first-ever product approved by the FDA last December for preventing recurrent C. difficile infections. Vowst is scheduled to be available in June.[2]

0. “FDA approves Seres Therapeutics' first fecal microbiota drug – Boston Business Journal” The Business Journals, 26 Apr. 2023, https://www.bizjournals.com/boston/news/2023/04/26/seres-therapeutics-ser-109-fda-approval-poop-pill.html

1. “FDA Approves First Orally Administered Fecal Microbiota Product for the Prevention of Recurrence of Clostridioides difficile Infection” Yahoo Finance, 26 Apr. 2023, https://finance.yahoo.com/news/fda-approves-first-orally-administered-225400985.html

2. “FDA approves Cambridge firm’s intestinal drug made from microorganisms in the gut” The Boston Globe, 26 Apr. 2023, https://www.bostonglobe.com/2023/04/26/business/fda-approves-cambridge-firms-intestinal-drug-made-microorganisms-gut/

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