PARSIPPANY, N.J.--(BUSINESS WIRE)--Ferring Pharmaceuticals today announced that REBYOTA™ (fecal microbiota, live – jslm) is now available in the United States (U.S.). REBYOTA is the first and only microbiome-based treatment approved by the U.S. Food and Drug Administration (FDA) to prevent recurrence of Clostridioides difficile (C. diff) infection in individuals 18 years of age and older, following antibiotic treatment for recurrent C. diff infection.
“With the launch of REBYOTA, Ferring is proud to offer an urgently needed new treatment option for adults suffering from the burden of recurrent C. diff infection,” said Brent Ragans, President, Ferring Pharmaceuticals U.S.
REBYOTA was approved by the U.S. FDA on November 30, 2022. The efficacy and safety of REBYOTA was studied in the largest clinical trial program in the field of microbiome-based therapeutics, including five clinical trials with more than 1,000 participants. REBYOTA is a single-dose treatment that is administered in minutes during one visit at the doctor’s office.
“The availability of REBYOTA is great news for people who are suffering from the devastating cycle of recurrent C. diff infection,” said Paul Feuerstadt, M.D., F.A.C.G., A.G.A.F., Yale University School of Medicine. “Healthcare providers can now offer an FDA-approved microbiome treatment and provide patients with new hope to help fight this infection.”
Resources for Patients
Ferring provides a variety of offerings, including co-pay and patient assistance programs, to allow for access to REBYOTA. Information about the REBYOTA programs is available from healthcare providers or at REBYOTA.com.
Resources for Healthcare Providers
Ferring offers educational programs as well as support programs for healthcare providers. The REBYOTA CONNECT program provides guidance to healthcare providers about access services, as well as information about co-pay and patient assistance programs. Information is available at 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 for a vicious cycle of recurrence, causing a significant burden for patients suffering from this debilitating and potentially deadly illness.1,8
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. Each dose of REBYOTA is delivered directly to the gut microbiome.
The FDA approval of REBYOTA was based on results from the randomized, double-blind, placebo-controlled Phase 3 PUNCH™ CD3 trial in which a single dose of REBYOTA demonstrated superiority to placebo as a treatment to reduce recurrent C. diff infection after standard-of-care antibiotic treatment. Two hundred sixty-two (262) trial participants received blinded treatment (n=177, REBYOTA; n=85, placebo) and the primary endpoint was treatment success, defined as the absence of C. diff infection diarrhea for eight weeks after completing study treatment. The Bayesian model-estimated treatment success rate at eight weeks for REBYOTA was 70.6% versus 57.5% for placebo, with a 99.1% posterior probability that REBYOTA was superior to placebo in reducing recurrent C. diff infection after standard-of-care antibiotic treatment.9 More than 90% of study participants who achieved treatment success remained free of recurrent C. diff infection through six months.10
In the study, adverse events (AEs) were primarily mild-to-moderate and there were no treatment-related serious adverse events (SAEs). Incidence of treatment-emergent adverse events (TEAEs) was higher in REBYOTA recipients compared with placebo (55.6%, n=100/180, REBYOTA; 44.8%, n=39/87, placebo), mostly driven by a higher incidence of mild gastrointestinal events.10
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 research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. In the United States, Ferring is a leader in reproductive medicine and maternal health, uro-oncology and in specialty areas within gastroenterology, including microbiome therapeutics, and orthopaedics. For more information, call 1-888-FERRING (1-888-337-7464) or visit http://www.ferringusa.com/.
Connect with us on our dedicated microbiome therapeutics development channels on Twitter and LinkedIn.
- Centers for Disease Control and Prevention. What Is C. Diff? 17 Dec. 2018. Available at: https://www.cdc.gov/cdiff/what-is.html.
- Centers for Disease Control and Prevention. 24 June 2020. Available at: https://www.cdc.gov/drugresistance/pdf/threats-report/clostridioides-difficile-508.pdf.
- Feuerstadt P, et al. 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;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.
- Lessa FC, Mu Y, Bamberg, WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015;372(9):825-834.
- REBYOTA. Prescribing information. Parsippany, NJ: Ferring Pharmaceuticals Inc; 2022.
- Khanna, S, Assi, M, Lee, C, et al. Efficacy and safety of RBX2660 in PUNCH CD3, a phase III, randomized, double-blind, placebo-controlled trial with a Bayesian primary analysis for the prevention of recurrent Clostridioides difficile infection. Drugs. 2022;82(15):1527-1538.