FDA approval of the first fecal microbiota product

Copenhagen, 2 December 2023 – November 30th, 2022 marked a new milestone for the microbiome field: the U.S. Food and Drugs Administration (FDA) approved the first fecal microbiota product.

Rebyota, developed by Rebiotix Inc., a Ferring Company, is approved for the prevention of recurrence of Clostridioides difficile infection (rCDI) in adults. This is a major accomplishment for the company, for our field, but also and most importantly, for the many patients suffering from rCDI.

Our CSO H. Bjørn Nielsen was interviewed by Liza Laws for Labiotech.eu, along with Dr James McIlroy, CEO of Enterobiotix, and Herve Affagard, CEO of MaaT Pharma: “It is incredibly exciting that Rebyota has received approval by the FDA. It is indeed an achievement for Rebiotix and Ferring, but also for the whole field of microbiome-based therapeutics, and even microbiome as such. Recurrent CDI is a deadly infectious disease, and I think it has been clear to many in the microbiome field that treatment like this could be a solution. I am convinced this first microbiome-based treatment will help many patients. It is very significant, and I am sure this will encourage the entire microbiome field going forward. Clinical Microbiomics is committed to supporting companies in the microbiome space to achieve similar goals.”

Read the article here.

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