- FDA approved to prevent recurrent C. difficile infection (rCDI), REBYOTA is widely available with a strong drug supply and dedicated manufacturing facility
- Since launch, Ferring created REBYOTA @ Home to help patients with rCDI across the U.S. receive treatment at home as well as health care settings
- Ferring continues to invest in new data, including real-world evidence reinforcing the impact of REBYOTA in patients with rCDI as well as an ongoing colonoscopy study
PARSIPPANY, N.J.--(BUSINESS WIRE)--Ferring Pharmaceuticals is celebrating the second anniversary of the launch of REBYOTA® (fecal microbiota, live – jslm), the first microbiome-based therapy approved by the U.S. Food and Drug Administration (FDA) for the prevention of recurrent C. difficile (C. diff) infection in individuals 18 years of age and older, following antibiotic treatment for C. diff infection.
Launched on January 23, 2023, REBYOTA has been administered to thousands of patients and offers an effective, well-tolerated therapy with convenient administration as a single dose by a healthcare professional in one visit.
“Access to FDA-approved treatments to prevent recurrent C. difficile infection remains critical for halting the vicious cycle of debilitating symptoms and suffering affecting patients with this infectious disease,” said Paul Feuerstadt, M.D., F.A.C.G., A.G.A.F., Yale School of Medicine and PACT-Gastroenterology Center. “Recent shifts in the treatment landscape, in which some options will no longer be available, may cause concerns about the future of rCDI care. With REBYOTA, however, patients and their healthcare providers should be reassured that they will continue to have access to an effective and well-tolerated FDA-approved therapy.”
REBYOTA Available for At-home Administration
While REBYOTA is administered in a simple procedure right in the doctor’s office, some patients may not be able to receive treatment in that setting because of location constraints, physical limitations, and administrative obstacles. To better support patients, Ferring created REBYOTA @ Home, a program available in all 50 states, coordinates and manages the process of in-home administration by a nurse.
“Since introducing REBYOTA, Ferring has remained committed to making this therapy accessible and available to patients with recurrent C. diff infection (rCDI), regardless of where they receive care,” said Raza Ahmed, MD, Senior Director of Medical Affairs, Ferring Pharmaceuticals. “This commitment is reflected in initiatives like our REBYOTA @ Home program, our dedicated U.S. manufacturing facility, and our sustained investment in clinical research. Our ongoing CDI-SCOPE study further demonstrates this dedication by exploring innovative treatment delivery methods, including administration via colonoscopy.”
Growing Body of Supporting Evidence
The FDA approval of REBYOTA was based on results from a clinical program that included the Phase 3 PUNCH™ CD3 trial, in which a single dose of REBYOTA demonstrated superiority to placebo as a treatment to reduce rCDI after standard-of-care antibiotic treatment. Overall, the clinical trial program for REBYOTA was the largest in the field of microbiome-based therapeutics, including five clinical trials with more than 1,000 participants.
Along with randomized, blinded, placebo-controlled trials, the safety and efficacy of REBYOTA also is supported by real-world evidence. In a retrospective study presented during Digestive Disease Week (DDW) 2024, nearly three out of four patients treated with REBYOTA had no CDI recurrence at eight weeks, despite having a high risk of recurrent infection. Another retrospective real-world study, presented at IDWeek 2024, showed similar results whether patients were treated at home or in a clinic.
Ferring is nearing completion of CDI-SCOPE, an investigational, multi-center, single-arm trial exploring the safety and clinical effectiveness of REBYOTA administered to adults with rCDI by colonoscopy. The company anticipates sharing results of this trial later this year.
To learn more about REBYOTA, in-home administration, and other information, please visit REBYOTA.com or www.REBYOTAHCP.com.
About C. diff infection
C. diff infection is a serious and potentially deadly infection that impacts people across the globe. The C. diff bacterium causes debilitating symptoms, such as severe diarrhea, fever, stomach tenderness or pain, loss of appetite, nausea and colitis (an inflammation of the colon).1 C. diff infection can be the start of a vicious cycle of recurrence, causing a significant burden for patients and the healthcare system.2,3 It has been estimated that up to 35% of C. diff infection cases recur after initial diagnosis and people who have had a recurrence are at significantly higher risk of further infections.4,5,6,7 After the first recurrence, it has been estimated that up to 65% of patients may develop a subsequent recurrence.6,7 Antibiotics – the current standard of care for treatment of C. diff infection – treat the disease but can also be a contributing factor to the cycle of recurrence.1
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 (fecal 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%), diarrhea (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.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a privately-owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. In the United States, Ferring is a leader in reproductive medicine, and in areas of gastroenterology and orthopaedics. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Our company was founded in 1950 and is headquartered in Saint-Prex, Switzerland. Ferring employs more than 7,000 people worldwide and markets its medicines in over 100 countries. Ferring USA is based in Parsippany, New Jersey, and employs more than 900 employees.
For more information, please visit www.ferringusa.com, call 1-888-FERRING (1-888-337-7464), or connect with us on LinkedIn, and X (Twitter).
References:
- Centers for Disease Control and Prevention. What is C. diff? 7 Sep. 2022. Available at: https://www.cdc.gov/c-diff/about/?CDC_AAref_Val=https://www.cdc.gov/cdiff/what-is.html.
- Centers for Disease Control and Prevention. 2019 Antibiotic Resistance Threats Report: Clostridioides difficile. 23 Nov. 2021. Available at: https://www.cdc.gov/antimicrobial-resistance/media/pdfs/clostridioides-difficile-508.pdf?CDC_AAref_Val=https://www.cdc.gov/drugresistance/pdf/threats-report/clostridioides-difficile-508.pdf.
- Feuerstadt P, et al. Healthcare resource utilization and direct medical costs associated with index and recurrent Clostridioides difficile infection: a real-world data analysis. J Med Econ. 2020;23(6):603-609.
- Riddle DJ, Dubberke ER. Clostridium difficile infection in the intensive care unit. Infect Dis Clin North Am. 2009;23(3):727-743.
- Nelson WW, et al. Health care resource utilization and costs of recurrent Clostridioides difficile infection in the elderly: a real-world claims analysis. J Manag Care Spec Pharm. 2021 Jul;27(7):828-838. doi: 10.18553/jmcp.2021.20395. Epub 2021 Mar 11.
- Kelly, CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012;18 (Suppl. 6): 21–27.
- Smits WK, et al. Clostridium difficile infection. Nat Rev Dis Primers. 2016;2:16020. doi: 10.1038/nrdp.2016.20.
Contacts
For more information, please contact:
Patrick Gorman
Senior Director, Corporate Communications
+1 862 286 5035
patrick.gorman@ferring.com
