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U.S. FDA APPROVES FIRST FECAL MICROFLORA PRODUCT

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2022.12.26

On November 30, 2022, the U.S. Food and Drug Administration (FDA) approved FerringPharma’s fecal microbiota product, Rebyota, for the treatment of rCDI, the first time the FDA has approved a fecal microbiota product.

Rebyota is approved for the prevention of recurrent recurrent Clostridioides  difficile infection (CDI) in patients 18 years of age and older. The drug is intended for patients 18 years of age and older with recurrent CDI who have completed treatment with antibiotic therapy and is administered as a single rectal dose. The application for Rebyota has been designated and approved as a Breakthrough Therapy, Expedited Approval, and Orphan Drug Application.

This approval represents a step forward in the treatment of patients with recurrent CDI,” said Peter Marks of the FDA’s Center for Biologics Evaluation and Research (CBER).

In this study, approximately 1,000 subjects received Rebyota, and the estimated success rate in preventing recurrent CDI was significantly higher in the Rebyota group (70.6%) than in the placebo group (57.5%).

THE FIRST FDA APPROVAL OF A FECAL MICROFLORA PRODUCT IS EXPECTED TO ACCELERATE THE DEVELOPMENT OF FMT AS A DRUG.


Reference Articles

FDA News Release
[FDA Approves First Fecal Microbiota Product] 30.11.2022
https://www.fda.gov/news-events/press-announcements/fda-approves-first-fecal-microbiota-product

Felling Press Release
[Felling Receives U.S. FDA Approval for
REBYOTA® (Fecal Microbiota, live-jslm)
– Novel First-in-Class Microbiota-Based Live Biopharmaceutical -] 2022.12.09
https://d2gohj824v350l.cloudfront.net/wp-content/uploads/sites/32/2022/12/08211836/20221209_pressrelease.pdf

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