As part of our ongoing transformation to sharpen our focus, we have decided to explore strategic options for Rebyota® (faecal microbiota, live – jslm). To date, more than five thousand patients suffering from recurrent Clostridioides difficile infection (rCDI) have found new hope when treated with Rebyota®. Without commercial critical mass in this therapy area at Ferring, we believe that this first-in-class, innovative product could benefit many more patients with a new approach to its continued commercialisation. As a result, Ferring will reduce commercial efforts in the United States while ensuring uninterrupted access for patients.
Approved by the U.S. Food and Drug Administration (FDA) in 2022, Rebyota® was the first FDA-approved faecal microbiota transplant, indicated for the prevention of rCDI in adults following antibiotic treatment for recurrent CDI. This milestone marked a significant advancement in understanding the role of the human microbiome in health and disease.
Ferring remains committed to advancing the science of the human microbiome to address significant unmet medical needs. The company intends to build on the valuable insights gained from the development and commercialisation of Rebyota® as it continues its efforts to advance second-generation microbiome therapies (non-donor-based, oral solutions designed to offer greater convenience for both healthcare professionals and patients) across other indications.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a privately owned specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine with a strong heritage in gastroenterology and urology and are at the forefront of innovation in uro-oncology gene therapy. Ferring was founded in 1950 and employs more than 7,500 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which market its medicines in over 100 countries.
Learn more at www.ferring.com, or connect with us on LinkedIn, Instagram, YouTube, Facebook and X.
About Rebyota®
Rebyota is a pre-packaged, single-dose 150 mL microbiota suspension for rectal administration consisting of a liquid mix of up to trillions of live microbes – including Bacteroides. Rebyota is delivered directly to the gut microbiome and is administered by a healthcare professional in one visit.
Indication
Rebyota® (faecal microbiota, live – jslm) is indicated for the prevention of recurrence of Clostridioides difficile (C. diff) infection in individuals 18 years of age and older, following antibiotic treatment for recurrent C. diff infection.
Limitation of Use
Rebyota is not indicated for the treatment of C. diff infection.
Important Safety Information
You should not receive Rebyota if you have a history of a severe allergic reaction (e.g., anaphylaxis) to Rebyota or any of its components.
You should report to your doctor any infection you think you may have acquired after administration.
Rebyota may contain food allergens.
Most common side effects may include stomach pain (8.9%), diarrhoea (7.2%), bloating (3.9%), gas (3.3%), and nausea (3.3%).
Rebyota has not been studied in patients below 18 years of age.
Clinical studies did not determine if adults 65 years of age and older responded differently than younger adults.
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088.
Please click to see the full Prescribing Information.
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Contact details:
For more information, please contact:
United States and Canada enquiries
Patrick Gorman
Senior Director, Corporate Communications
[email protected]
Global enquiries
Björn Lindström
Director, Corporate Communications
[email protected]
